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The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator | + placebo |
|
| A2 | Experimental | + placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin + Placebo | Drug | Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects | An Independent Central Adjudication Committee (ICAC) adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). Surgery=Day 1; Randomization/Treatment started on Day of Surgery or the next day (Day 1 or Day 2). A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. Intended Treatment Period=starts on the day of randomization; for treated participants, the period ends at the latter of 2 days after last dose of study drug or 14 days after the first dose of study drug; for randomized participants who were not treated, the period ends 14 days after randomization. | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
| Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population | ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Clinically relevant (CR); Non-Major (N-M) Bleeding. Day 1=Day of surgery. Treatment started (first dose) day of surgery or next day. Treatment continued for 12 days. | First dose of study drug to last dose, plus 2 days post last dose |
| Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period | ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Follow up Period was from the end of the treatment period (last dose) up to 60 days post last dose, Day 72. |
| Measure | Description | Time Frame |
|---|---|---|
| Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period | A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected proximal DVT and non-fatal PE, and all-cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capstone Clinical Trials, Inc | Birmingham | Alabama | 35205 | United States | ||
| Capstone Clinical Trials, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35570249 | Derived | Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16. | |
| 19657123 | Derived |
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3608 patients enrolled and 3195 were randomized to double blind (DB) Treatment Period: 413 not randomized due to: 227 no longer met criteria, 109 withdrew consent, 60 other reasons, 11 administrative reason by sponsor, 5 adverse event, 1 poor, non-compliance.
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| ID | Title | Description |
|---|---|---|
| FG000 | Apixaban 2.5mg BID | Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug (day of surgery or next day); and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| DB Treatment Period-Randomized Patients |
|
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| Apixaban + Placebo | Drug | Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period |
|
| Last dose of study drug to Day 72 (60 days) |
| From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
| Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period | VTE / VTE-related death was defined as the combination of fatal or non-fatal PE, and symptomatic or asymptomatic DVT. A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
| Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period | An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
| Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period | ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
| Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period | ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. VTE includes DVT and PE. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
| Event Rate for Participants With All-Cause Death During the Intended Treatment Period | Event rate was number of participants with all-cause death divided by the number of participant's analyzed (%). | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
| Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period | ICAC adjudicated cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
| Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period | ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
| Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period | ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
| Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period | ICAC adjudicated VTE, acute clinically overt bleeding events, suspected thrombocytopenia, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
| Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period | An ICAC adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
| Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period | ICAC adjudicated all venograms and suspected symptomatic DVT. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
| Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period | ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). | From first dose to last dose, plus 2 days (12 days, plus 2) |
| Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period | A 60-day follow-up period started after the last dose of study drug and continued until the End of Study Visit on Day 72 (60 days ± 3 days, after the last dose of study drug). Event rate was number of participants with the endpoint divided by the number of participants analyzed (%). ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per ISTH guidelines modified for surgical patients. | Post last dose of study drug to Day 72 (60 days) |
| Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | First dose to last dose, plus 2 days for AEs (12 + 2 days) or plus 30 days for SAEs (12 + 30 days) |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Blood pressures (BP) were measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Systolic and diastolic pressures were measured in millimeters of mercury (mmHg). | Baseline to last dose of study drug, plus 2 days |
| Mean Change From Baseline in Heart Rate During the Treatment Period | Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Heart rate was measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Heart rate was measured in beats per minute (bpm). | Baseline to last dose of study drug, plus 2 days |
| Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period | Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Hematology profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 2, 3, 4, 12 (end of treatment). Upper limit of normal (ULN); lower limit of normal (LLN). Platelet Count low: < 100,000/mm^3 (or < 100*109 cells/L). Erythrocytes low: < 0.75 *pre-dose. Hemoglobin low: > 2 g/dL decrease compared to pre-dose or Value ≤ 8 g/dL. Hematocrit low: < 0.75*pre-dose . Leukocytes: < 0.75*LLN or > 1.25* ULN, or if pre-dose < LLN then use < 0.8*predose or > ULN if pre-dose > ULN then use > 1.2*predose or < LLN. Lymphocytes (absolute): < 0.750*10^3 cells/µL or > 7.50*10^3 cells/ µL. Eosinophils (absolute) high: > 0.750*10^3 cells/µL. Basophils(absolute) high: > 400/mm^3 (or > 0.4*103 cells/µL). Monocytes (absolute) high: > 2000/mm^3 (or > 2*103 cells/µL). Neutrophils(absolute) high: < 1.0*103 cells/µL. | First dose to last dose of study drug (12 days), plus 2 days |
| Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period | Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Bilirubin (direct) high: > 1.5*ULN. Total bilirubin: : > 2*ULN, Alanine Aminotransferase (ALT) high: > 3*ULN. Alkaline Phosphatase (ALP): > 2*ULN. Aspartate Aminotransferase (AST): > 3*ULN. Creatinine: > 1.5*ULN. | First dose to last dose of study drug (12 days), plus 2 days |
| Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period | Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Potassium: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Calcium: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN If pre-dose > ULN then use > 1.25*predose or < LLN. Chloride: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Sodium: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*predose or >ULN if pre-dose > ULN then use > 1.05*predose or < LLN. Bicarbonate: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN if pre-dose > ULN then use > 1.25*predose or < LLN. | First dose to last dose of study drug (12 days), plus 2 days |
| Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period | Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Fasting Glucose: if pre-dose < LLN then use < 0.8*predose; or > ULN if pre-dose > ULN then use > 2.0*predose or <LLN. Total Protein: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9*predose or > ULN if pre-dose > ULN then use 1.1*predose or < LLN. Uric Acid: > 1.5*ULN, or if pre-dose > ULN then use > 2*predose. Creatine Kinase (CK): > 5*ULN. | First dose to last dose of study drug (12 days), plus 2 days |
| Birmingham |
| Alabama |
| 35209 |
| United States |
| West Alabama Research, Inc. | Tuscaloosa | Alabama | 35406 | United States |
| Martin Bowen Hefley Orthopedics | Little Rock | Arkansas | 72205 | United States |
| Colorado Orthopedic Consultants, Pc | Aurora | Colorado | 80012 | United States |
| Colorado Joint Replacement | Denver | Colorado | 80210 | United States |
| Jdpmedical Research | Denver | Colorado | 80230 | United States |
| Orhtopaedic Physicians Of Colorado, P.C. | Englewood | Colorado | 80113 | United States |
| Orthopedics Assocs Of Hartford | Hartford | Connecticut | 06106 | United States |
| Anthony S. Unger, Md | Washington D.C. | District of Columbia | 20006 | United States |
| Bay Pines Va Medical Center | Bay Pines | Florida | 33744 | United States |
| Pab Clinical Research | Brandon | Florida | 33511 | United States |
| Jacksonville Center For Clinical Research | Jacksonville | Florida | 32216 | United States |
| Mark W. Hollmann, Md | Orange City | Florida | 32763 | United States |
| Jewett Orthopaedic Clinic | Winter Park | Florida | 32789 | United States |
| Atlanta Knee And Sports Medicine | Decatur | Georgia | 30033 | United States |
| Americana Orthopedics | Boise | Idaho | 83702 | United States |
| Intermountain Orthopaedics | Boise | Idaho | 83702 | United States |
| Bluegrass Orthopaedics/Bmr | Lexington | Kentucky | 40509 | United States |
| Charleston Orthopaedic Assocs. | Charleston | South Carolina | 29414 | United States |
| Kelsey Seybold Clinic | Houston | Texas | 77025 | United States |
| Bone & Joint Clinic Of Houston | Houston | Texas | 77030 | United States |
| Gill Orthopedic Center | Lubbock | Texas | 79410 | United States |
| Robert R. King, Md | Lubbock | Texas | 79410 | United States |
| Unlimited Research | San Antonio | Texas | 78217 | United States |
| Local Institution | Buenos Aires | Buenos Aires | 1280 | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | 1425 | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | 7540 | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | C1181 | Argentina |
| Local Institution | Capital Federal | Buenos Aires | 1012 | Argentina |
| Local Institution | Capital Federal | Buenos Aires | 1426 | Argentina |
| Local Institution | Córdoba | Córdoba Province | 5000 | Argentina |
| Local Institution | Garran | Australian Capital Territory | 2605 | Australia |
| Local Institution | Camperdown | New South Wales | NSW 2050 | Australia |
| Local Institution | Caringbah | New South Wales | 2229 | Australia |
| Local Institution | Lismore | New South Wales | 2480 | Australia |
| Local Institution | Gold Coast | Queensland | 4215 | Australia |
| Local Institution | Adelaide | South Australia | 5011 | Australia |
| Local Institution | Bedford Park | South Australia | 5042 | Australia |
| Local Institution | Box Hill | Victoria | 3128 | Australia |
| Local Institution | Windsor | Victoria | 3181 | Australia |
| Local Institution | Perth | Western Australia | 6001 | Australia |
| Local Institution | Curitiba | Paraná | 80060 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035 | Brazil |
| Local Institution | Porto Alegre, Rs | Rio Grande do Sul | 90020 | Brazil |
| Local Institution | Campinas | São Paulo | 13083 | Brazil |
| Local Institution | São Paulo | São Paulo | 05403 | Brazil |
| Local Institution | Edmonton | Alberta | T6G 2R7 | Canada |
| Local Institution | Ajax | Ontario | L1S 2J5 | Canada |
| Local Institution | Burlington | Ontario | L7R 4B7 | Canada |
| Local Institution | Cambridge | Ontario | N1R 7L7 | Canada |
| Local Institution | Chatham | Ontario | N7L 4T1 | Canada |
| Local Institution | Dartmouth | Ontario | B2Y 2N6 | Canada |
| Local Institution | Guelph | Ontario | N1E 6L9 | Canada |
| Local Institution | Lindsay | Ontario | K9V 4M8 | Canada |
| Local Institution | Newmarket | Ontario | L3Y 5G8 | Canada |
| Local Institution | Niagara Falls | Ontario | L2E 6X2 | Canada |
| Local Institution | Sarnia | Ontario | N7T 6H3 | Canada |
| Local Institution | Scarborough Village | Ontario | M1S 4T7 | Canada |
| Local Institution | Scarborough Village | Ontario | M3C 1W3 | Canada |
| Local Institution | St. Catharines | Ontario | L2R 7P3 | Canada |
| Local Institution | Stratford | Ontario | N5A 2N4 | Canada |
| Local Institution | Waterloo | Ontario | N2J 1C4 | Canada |
| Local Institution | Windsor | Ontario | N8W 1E6 | Canada |
| Local Institution | Charlottetown | Prince Edward Island | C1A 1L2 | Canada |
| Local Institution | Montreal | Quebec | H4J 1C5 | Canada |
| Local Institution | Québec | Quebec | G1L 3L5 | Canada |
| Local Institution | Hørsholm | 2970 | Denmark |
| Local Institution | Kopenhamn S | 2300 | Denmark |
| Local Institution | Kecskemét | 6000 | Hungary |
| Local Institution | Székesfehérvár | 8000 | Hungary |
| Local Institution | Szolnok | 5008 | Hungary |
| Local Institution | Afula | 18101 | Israel |
| Local Institution | Beersheba | 84101 | Israel |
| Local Institution | Haifa | 31096 | Israel |
| Local Institution | Holon | 58100 | Israel |
| Local Institution | Kfar Saba | 44281 | Israel |
| Local Institution | Petah Tikva | 49100 | Israel |
| Local Institution | Rehovot | 76100 | Israel |
| Local Institution | Ẕerifin | 70300 | Israel |
| Local Institution | Chihuahua City | Chihuahua | 31000 | Mexico |
| Local Institution | Tijuana | Estado de Baja California | 22010 | Mexico |
| Local Institution | Guadalajara | Jalisco | 44280 | Mexico |
| Local Institution | Df | Mexico City | 01030 | Mexico |
| Local Institution | Df | Mexico City | 05300 | Mexico |
| Local Institution | Df | Mexico City | 07760 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64000 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64460 | Mexico |
| Local Institution | Ciudad Madero | Tamaulipas | 89240 | Mexico |
| Local Institution | Jalapa | Veracruz | 91020 | Mexico |
| Local Institution | Mérida | Yucatán | 97070 | Mexico |
| Local Institution | Mérida | Yucatán | 97133 | Mexico |
| Local Institution | Bialystok | 15276 | Poland |
| Local Institution | Krakow | 31-826 | Poland |
| Local Institution | Lodz | 91002 | Poland |
| Local Institution | Lublin | 20954 | Poland |
| Local Institution | Szczecin | 71252 | Poland |
| Local Institution | Warsaw | 00909 | Poland |
| Local Institution | Warsaw | 02005 | Poland |
| Local Institution | Moscow | 117333 | Russia |
| Local Institution | Saint Petersburg | 195257 | Russia |
| Local Institution | Samara | 443095 | Russia |
| Local Institution | Gothenburg | 416 85 | Sweden |
| Local Institution | Adana | 01330 | Turkey (Türkiye) |
| Local Institution | Bursa | 16059 | Turkey (Türkiye) |
| Local Institution | Mersin | 33163 | Turkey (Türkiye) |
| Local Institution | Trabzon | 61030 | Turkey (Türkiye) |
| Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med. 2009 Aug 6;361(6):594-604. doi: 10.1056/NEJMoa0810773. |
| FG001 | Enoxaparin 30 mg SC Injection q 12 Hours | Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug(day of surgery or next day); and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72). |
| COMPLETED |
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| NOT COMPLETED |
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|
| Follow-Up Period - Randomized Patients |
|
|
Randomized participants were summarized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Apixaban 2.5mg BID | Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72). |
| BG001 | Enoxaparin 30 mg SC Injection q 12 Hours | Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects | An Independent Central Adjudication Committee (ICAC) adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). Surgery=Day 1; Randomization/Treatment started on Day of Surgery or the next day (Day 1 or Day 2). A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. Intended Treatment Period=starts on the day of randomization; for treated participants, the period ends at the latter of 2 days after last dose of study drug or 14 days after the first dose of study drug; for randomized participants who were not treated, the period ends 14 days after randomization. | Primary Population=All randomized participants who: have an adjudicated and evaluable bilateral venogram performed during the Intended Treatment Period; or have an adjudicated VTE during the Intended Treatment Period; or die due to any cause during the Intended Treatment Period. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
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| Secondary | Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period | A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected proximal DVT and non-fatal PE, and all-cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated non-fatal PE or death, during the Intended Treatment Period, were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
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| Secondary | Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period | VTE / VTE-related death was defined as the combination of fatal or non-fatal PE, and symptomatic or asymptomatic DVT. A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | Randomized participants with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
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| Secondary | Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period | An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
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| Secondary | Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period | ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
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| Secondary | Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period | ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. VTE includes DVT and PE. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
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| Secondary | Event Rate for Participants With All-Cause Death During the Intended Treatment Period | Event rate was number of participants with all-cause death divided by the number of participant's analyzed (%). | All Randomized participants were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
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| Secondary | Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period | ICAC adjudicated cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | All randomized participants were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
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| Secondary | Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period | ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | All randomized participants were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
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| Secondary | Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period | ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | All randomized participants were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
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| Secondary | Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period | ICAC adjudicated VTE, acute clinically overt bleeding events, suspected thrombocytopenia, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). | Randomized participants with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
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| Secondary | Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period | An ICAC adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). | All randomized participants: PE, Symptomatic DVT, Symptomatic Proximal DVT, Symptomatic Distal DVT. Randomized with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint: All DVT, Asymptomatic DVT. n=number analyzed in each category | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
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| Secondary | Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period | ICAC adjudicated all venograms and suspected symptomatic DVT. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). | Randomized participants with either an adjudicated and evaluable bilateral proximal (or distal, as appropriate) venogram or an adjudicated event associated with the endpoint. n= number analyzed | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization |
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| Secondary | Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period | ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). | All participants who received at least one dose of study drug were analyzed (Treated Population). | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose to last dose, plus 2 days (12 days, plus 2) |
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| Primary | Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population | ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Clinically relevant (CR); Non-Major (N-M) Bleeding. Day 1=Day of surgery. Treatment started (first dose) day of surgery or next day. Treatment continued for 12 days. | All participants who received at least one dose of study drug (Treated population). | Posted | Number | 95% Confidence Interval | percentage of participants | First dose of study drug to last dose, plus 2 days post last dose |
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| Primary | Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period | ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Follow up Period was from the end of the treatment period (last dose) up to 60 days post last dose, Day 72. | All participants who received at least 1 dose of study drug during the Treatment Period and entered the Follow-Up Period. | Posted | Number | 95% Confidence Interval | percentage of participants | Last dose of study drug to Day 72 (60 days) |
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| Secondary | Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period | A 60-day follow-up period started after the last dose of study drug and continued until the End of Study Visit on Day 72 (60 days ± 3 days, after the last dose of study drug). Event rate was number of participants with the endpoint divided by the number of participants analyzed (%). ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per ISTH guidelines modified for surgical patients. | Participants who received at least one dose of study drug and entered the Follow-Up period | Posted | Number | 95% Confidence Interval | percentage of participants | Post last dose of study drug to Day 72 (60 days) |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | All participants who received at least 1 dose of study drug during the Treatment Period. | Posted | Number | participants | First dose to last dose, plus 2 days for AEs (12 + 2 days) or plus 30 days for SAEs (12 + 30 days) |
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| Secondary | Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Blood pressures (BP) were measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Systolic and diastolic pressures were measured in millimeters of mercury (mmHg). | All participants who received at least one dose of study drug and had blood pressure measurements at baseline were summarized. | Posted | Mean | Standard Error | mmHg | Baseline to last dose of study drug, plus 2 days |
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| Secondary | Mean Change From Baseline in Heart Rate During the Treatment Period | Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Heart rate was measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Heart rate was measured in beats per minute (bpm). | All participants who received at least one dose of study drug and had heart rate measurements at baseline were summarized. | Posted | Mean | Standard Error | bpm | Baseline to last dose of study drug, plus 2 days |
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| Secondary | Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period | Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Hematology profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 2, 3, 4, 12 (end of treatment). Upper limit of normal (ULN); lower limit of normal (LLN). Platelet Count low: < 100,000/mm^3 (or < 100*109 cells/L). Erythrocytes low: < 0.75 *pre-dose. Hemoglobin low: > 2 g/dL decrease compared to pre-dose or Value ≤ 8 g/dL. Hematocrit low: < 0.75*pre-dose . Leukocytes: < 0.75*LLN or > 1.25* ULN, or if pre-dose < LLN then use < 0.8*predose or > ULN if pre-dose > ULN then use > 1.2*predose or < LLN. Lymphocytes (absolute): < 0.750*10^3 cells/µL or > 7.50*10^3 cells/ µL. Eosinophils (absolute) high: > 0.750*10^3 cells/µL. Basophils(absolute) high: > 400/mm^3 (or > 0.4*103 cells/µL). Monocytes (absolute) high: > 2000/mm^3 (or > 2*103 cells/µL). Neutrophils(absolute) high: < 1.0*103 cells/µL. | All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group. | Posted | Number | participants | First dose to last dose of study drug (12 days), plus 2 days |
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| Secondary | Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period | Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Bilirubin (direct) high: > 1.5*ULN. Total bilirubin: : > 2*ULN, Alanine Aminotransferase (ALT) high: > 3*ULN. Alkaline Phosphatase (ALP): > 2*ULN. Aspartate Aminotransferase (AST): > 3*ULN. Creatinine: > 1.5*ULN. | All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group. | Posted | Number | participants | First dose to last dose of study drug (12 days), plus 2 days |
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| Secondary | Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period | Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Potassium: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Calcium: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN If pre-dose > ULN then use > 1.25*predose or < LLN. Chloride: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Sodium: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*predose or >ULN if pre-dose > ULN then use > 1.05*predose or < LLN. Bicarbonate: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN if pre-dose > ULN then use > 1.25*predose or < LLN. | All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group. | Posted | Number | participants | First dose to last dose of study drug (12 days), plus 2 days |
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| Secondary | Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period | Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Fasting Glucose: if pre-dose < LLN then use < 0.8*predose; or > ULN if pre-dose > ULN then use > 2.0*predose or <LLN. Total Protein: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9*predose or > ULN if pre-dose > ULN then use 1.1*predose or < LLN. Uric Acid: > 1.5*ULN, or if pre-dose > ULN then use > 2*predose. Creatine Kinase (CK): > 5*ULN. | All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group. | Posted | Number | participants | First dose to last dose of study drug (12 days), plus 2 days |
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First dose to last dose, plus 2 days for AEs or plus 30 days for SAEs.
All participants who received at least one dose of study drug were included.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Apixaban 2.5mg BID | Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72). | 123 | 1,596 | 713 | 1,596 | ||
| EG001 | Enoxaparin 30 mg SC Injection q 12 Hours | Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72). | 123 | 1,588 | 741 | 1,588 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Fat embolism | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Incision site infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Therapeutic response decreased | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Blood pressure fluctuation | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bloody discharge | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Wound haemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Clostridium difficile toxin test positive | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Delirium tremens | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Blood culture positive | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Medical device complication | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Secretion discharge | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Incision site cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Joint ankylosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Post procedural cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
Not provided
Not provided
| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Lost to Follow-up |
|
| non-specified |
|
| Greater than, equal to (>=) 65 and < 75 years |
|
| >=75 years |
|
| Male |
|
| Russian Federation |
|
| Hungary |
|
| United States |
|
| Canada |
|
| Sweden |
|
| Turkey |
|
| Denmark |
|
| Brazil |
|
| Poland |
|
| Mexico |
|
| Israel |
|
| Australia |
|
| Norway |
|
|
| t-test, 1 sided |
| <0.0001 |
If p-value is less than 0.025, it is statistically significant. |
| Risk Difference (RD) |
| 0.11 |
| 2-Sided |
| 95 |
| -2.22 |
| 2.44 |
| Yes |
| Non-Inferiority or Equivalence |
Two criteria were to be met to demonstrate non-inferiority: the upper bound of the 95% CI for the relative risk should be < 1.25, and the upper bound of the 95% CI for the risk difference should be < 5.6%. |
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days. |
|
|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|