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| ID | Type | Description | Link |
|---|---|---|---|
| EUdraCT: 2006-006896-19 |
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The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban, 2.5 mg BID + Placebo | Experimental | Participants received apixaban, 2.5-mg tablets twice daily (BID), plus a matching enoxaparin-placebo injection 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery. |
|
| Enoxaparin, 40 mg QD + Placebo | Active Comparator | Participants received enoxaparin, 40-mg subcutaneous injection once daily (QD), plus a matching apixaban-placebo tablet 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | 40 mg, administered once daily by subcutaneous injection, for 12 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period | Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization.Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause. | Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period | Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization; for randomized patients who did not receive study drug, the period ends 14 days after randomization. Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause. |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements) | preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal; abs=absolute. Hemoglobin (g/dL): >2 decrease from preRx value or value <=8; hematocrit (%): <0.75*preRx; platelets: <100*10^9 cells/L; erythrocytes (*10^6 cells/μL): <0.75*preRx; leukocytes: <0.75*LLN or >1.25*ULN, or if preRx <LLN, use <0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or <LLN; abs basophils: >400/mm^3; abs eosinophils: > 0.750*10^3 cells/µL; abs lymphocytes: <0.750*10*3 cells/ µL or >7.50*10^3 c/ µL; abs monocytes > 2000/mm^3; abs neutrophils: <1.0*10^3 cells/μL; ALP (U/L): >2*ULN; ALT, AST (U/L): >3*ULN; U/L; bilirubin, direct (mg/dL): >1.5*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN. |
Key Inclusion Criteria
Key Exclusion Criteria
Known or suspected hereditary or acquired bleeding or coagulation disorders in the participant or his or her first-degree relative
Known or suspected history of heparin-induced thrombocytopenia
Known coagulopathy
Active bleeding or at high risk for bleeding
Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
Active hepatobiliary disease
Alcohol and/or substance abuse within the past year
Any condition for which, in the opinion of the investigator, surgery or administration of an anticoagulant was contraindicated
Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure >180 mm Hg or supine diastolic blood pressure >105 mm Hg
Clinically significant laboratory abnormalities at the enrollment visit:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Graz | 8036 | Austria | |||
| Local Institution |
| 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. | |
| 23279103 | Derived |
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Of 3221 patients enrolled, 3057 were randomized. Primary participants=those who were randomized and had an adjudicated evaluable bilateral venogram or an adjudicated venous thromboembolic event or died. Evaluable participants=those with significant protocol deviations expected to affect the primary endpoint.
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| ID | Title | Description |
|---|---|---|
| FG000 | Apixaban, 2.5 mg BID + Placebo | Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD) |
| FG001 | Enoxaparin, 40 mg QD + Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Apixaban | Drug | 2.5 mg, administered twice daily as tablets, for 12 days |
|
|
| Enoxaparin-matching placebo | Drug | Administered once daily by subcutaneous injection |
|
| Apixaban-matching placebo | Drug | Oral tablet administered twice daily |
|
| Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study |
| Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM | Event rate=Number of events divided by number of patients evaluated. Adjusted difference of event rates takes into consideration type of surgery as a stratification factor. Bleeding Criteria: Major bleeding=an event consisting of clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. CRNM bleeding= clinically overt bleeding; that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event; that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding; or a change in antithrombic treatment. | Days 1 to 12 |
| Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome | 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. Bleeding AEs=all serious or nonserious bleeding-related AEs. | Days 1 through 12 + 2 days (nonserious AEs, bleeding AES) or 30 days (SAES, deaths) after last dose of study drug |
| Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up |
| Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements) | preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRx<LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; chloride, serum (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx<LLN use <0.9*preRx or >ULN if preRx>ULN use >1.1*preRx or <LLN; bicarbonate (mEq/L): <0.75*LLN or >1.25*ULN, or if preRx < LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or < LLN; potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRx<LLN use <0.9 *preRx or >ULN if preRx>ULN use >1.1*preRx or <LLN; sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRx <LLN use <0.95*preRx or >ULN if preRx>ULN use >1.05*preRx or <LLN; protein, total (g/dL): <0.9*LLN or >1.1*ULN, or if preRx <LLN use 0.9*preRx or >ULN if preRx >ULN use 1.1*preRx or <LLN; CK (U/L): >5*ULN; uric acid (mg/dL): >1.5*ULN, or if preRx >ULN use >2*preRx; glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRx <LLN use <0.8*preRx or >ULN. | Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up |
| Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis) | preRX=pretreatment. Blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; glucose, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; protein, urine: If missing preRx use ≥ 2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; Red blood cells , urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; white blood cells, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4. | Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (± 5 days) of follow-up |
| Innsbruck |
| 6020 |
| Austria |
| Local Institution | Linz | 4010 | Austria |
| Local Institution | Vienna | 1090 | Austria |
| Local Institution | Vienna | 1130 | Austria |
| Local Institution | Wels | 4600 | Austria |
| Local Institution | Wiener Neustadt | 2700 | Austria |
| Local Institution | Antwerp | 2020 | Belgium |
| Local Institution | Hasselt | 3500 | Belgium |
| Local Institution | Belo Horizonte - Mg | Minas Gerais | 30130 | Brazil |
| Local Institution | São Paulo | São Paulo | 04023 | Brazil |
| Local Institution | Santiago | Santiago Metropolitan | 7500922 | Chile |
| Local Institution | Santiago | Santiago Metropolitan | 8330033 | Chile |
| Local Institution | Beijing | Beijing Municipality | 100035 | China |
| Local Institution | Beijing | Beijing Municipality | 100835 | China |
| Local Institution | Qingdao | Shandong | 266003 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200011 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200025 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200233 | China |
| Local Institution | Bogotá | XXXXX | Colombia |
| Local Institution | Bogotá | Colombia |
| Local Institution | Cali | Colombia |
| Local Institution | MedellÃn | Colombia |
| Local Institution | Brno | 662 50 | Czechia |
| Local Institution | Chomutov | 430 12 | Czechia |
| Local Institution | Pardubice | 532 03 | Czechia |
| Local Institution | Prague | 180 81 | Czechia |
| Local Institution | Uherské Hradiště | 686 68 | Czechia |
| Local Institution | Hellerup | 2900 | Denmark |
| Local Institution | Hvidovre | 2650 | Denmark |
| Local Institution | Kolding | 6000 | Denmark |
| Local Institution | Viborg | 8800 | Denmark |
| Local Institution | Monaco | 98000 | France |
| Local Institution | Nice | 06200 | France |
| Local Institution | Paris | 75014 | France |
| Local Institution | Paris | 75019 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Saint-Saulve | 59880 | France |
| Local Institution | Bad Mergentheim | 97980 | Germany |
| Local Institution | Bochum | 44791 | Germany |
| Local Institution | Brandenburg | 14770 | Germany |
| Local Institution | Dresden | 01307 | Germany |
| Local Institution | Frankfurt | 65929 | Germany |
| Local Institution | Frankfurt am Main | 60528 | Germany |
| Local Institution | Halle/S | 06112 | Germany |
| Local Institution | Kremmen Ot Sommerfeld | 16766 | Germany |
| Local Institution | Rheinfelden | 79618 | Germany |
| Local Institution | Witten | 58455 | Germany |
| Local Institution | Szeged | 6725 | Hungary |
| Local Institution | Szekszárd | 7100 | Hungary |
| Local Institution | Ahmedabad | Gujarat | 380054 | India |
| Local Institution | Ludhiana | Punjab | 141001 | India |
| Local Institution | Bangalore | 560034 | India |
| Local Institution | Baroda | 390007 | India |
| Local Institution | Mangalore | 575001 | India |
| Local Institution | Jeruselem | 91031 | Israel |
| Local Institution | Petah Tikva | 49372 | Israel |
| Local Institution | Safed | 13110 | Israel |
| Local Institution | Tel Aviv | 64239 | Israel |
| Local Institution | Tel Litwinsky | 52621 | Israel |
| Local Institution | Abano Terme (Pd) | 35031 | Italy |
| Local Institution | Bologna | 40136 | Italy |
| Local Institution | Pordenone | 33170 | Italy |
| Local Institution | Roma | 00168 | Italy |
| Local Institution | San Donato Milanese (Mi) | 20097 | Italy |
| Local Institution | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Local Institution | Kuala Lumpur | Kuala Lumpur | 56000 | Malaysia |
| Local Institution | Aguascalientes | Aguascalientes | 20010 | Mexico |
| Local Institution | Zapopan | Jalisco | 45200 | Mexico |
| Local Institution | San Luis Potosà City | San Luis Potosà | 78340 | Mexico |
| Local Institution | Hermosillo | Sonora | 83190 | Mexico |
| Local Institution | Veracruz | Veracruz | 91700 | Mexico |
| Local Institution | Ã…lesund | 6026 | Norway |
| Local Institution | Gjettum | 1346 | Norway |
| Local Institution | Kongsvinger | 2212 | Norway |
| Local Institution | Manila | 1000 | Philippines |
| Local Institution | Quezon City | 1102 | Philippines |
| Local Institution | Quezon City | 1114 | Philippines |
| Local Institution | Bytom | 41-902 | Poland |
| Local Institution | Gdansk | 80-803 | Poland |
| Local Institution | Warsaw | 03-242 | Poland |
| Local Institution | Wroclaw | 50-556 | Poland |
| Local Institution | Chelyabinsk | 454021 | Russia |
| Local Institution | Kazan' | 420029 | Russia |
| Local Institution | Lipetsk | 398035 | Russia |
| Local Institution | Moscow | 115522 | Russia |
| Local Institution | Rostov-on-Don | 344010 | Russia |
| Local Institution | Saint Petersburg | 193312 | Russia |
| Local Institution | Saint Petersburg | 194354 | Russia |
| Local Institution | Saint Petersburg | 195427 | Russia |
| Local Institution | Saint Petersburg | 199106 | Russia |
| Local Institution | Samara | 443095 | Russia |
| Local Institution | Singapore | 169608 | Singapore |
| Local Institution | Singapore | 529889 | Singapore |
| Local Institution | Randburg | Free State | 2194 | South Africa |
| Local Institution | Johannesburg | Gauteng | 2031 | South Africa |
| Local Institution | Johannesburg | Gauteng | 2193 | South Africa |
| Local Institution | Pretoria | Gauteng | 0083 | South Africa |
| Local Institution | Somerset West | Western Cape | 7130 | South Africa |
| Local Institution | Tygerberg | Western Cape | 7505 | South Africa |
| Local Institution | Worcester | Western Cape | 6850 | South Africa |
| Local Institution | Jeonnam | 519-809 | South Korea |
| Local Institution | Seoul | 110-744 | South Korea |
| Local Institution | Seoul | 136-705 | South Korea |
| Local Institution | Seoul | 138-736 | South Korea |
| Local Institution | Badalona-Barcelona | 08916 | Spain |
| Local Institution | Barcelona | 08006 | Spain |
| Local Institution | Barcelona | 08024 | Spain |
| Local Institution | Barcelona | 08035 | Spain |
| Local Institution | Madrid | 28034 | Spain |
| Local Institution | Santiago de Compostela | 15706 | Spain |
| Local Institution | Valencia | 46010 | Spain |
| Local Institution | Borås | 501 82 | Sweden |
| Local Institution | Cherkassy | 18009 | Ukraine |
| Local Institution | Chernivtsy | 58013 | Ukraine |
| Local Institution | Dnipropetrovsk | 49005 | Ukraine |
| Local Institution | Ivano-Frankivsk | 76008 | Ukraine |
| Local Institution | Kyiv | 01601 | Ukraine |
| Local Institution | Kyiv | 04107 | Ukraine |
| Local Institution | Sevastopol | 99018 | Ukraine |
| Local Institution | London | Greater London | SE5 9PJ | United Kingdom |
| Local Institution | Epsom | Surrey | KT18 7EG | United Kingdom |
| Pineo GF, Gallus AS, Raskob GE, Chen D, Ramirez LM, Ramacciotti E, Lassen MR, Wang L. Apixaban after hip or knee arthroplasty versus enoxaparin: efficacy and safety in key clinical subgroups. J Thromb Haemost. 2013 Mar;11(3):444-51. doi: 10.1111/jth.12109. |
| 20206776 | Derived | Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P; ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet. 2010 Mar 6;375(9717):807-15. doi: 10.1016/S0140-6736(09)62125-5. |
Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
| Received Treatment |
|
| Evaluable Participants |
|
| Primary Participants |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
All participants randomized to treatment
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Apixaban, 2.5 mg BID + Placebo | Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD) |
| BG001 | Enoxaparin, 40 mg QD + Placebo | Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID |
| 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 | Median | Standard Deviation | Years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | Participants |
| ||||||||||||||||
| Type of Risk Factor | Number | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period | Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization; for randomized patients who did not receive study drug, the period ends 14 days after randomization. Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause. | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period | Posted | Number | 95% Confidence Interval | Percentage of events/patients evaluated | Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study |
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| Secondary | Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM | Event rate=Number of events divided by number of patients evaluated. Adjusted difference of event rates takes into consideration type of surgery as a stratification factor. Bleeding Criteria: Major bleeding=an event consisting of clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. CRNM bleeding= clinically overt bleeding; that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event; that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding; or a change in antithrombic treatment. | All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of events/patients evaluated | Days 1 to 12 |
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| Primary | Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period | Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization.Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause. | The primary efficacy data set (all randomized participants who, during the Intended Treatment Period, had an adjudicated and evaluable bilateral venogram, an adjudicated venous thrombolytic event; or died due to any cause.) | Posted | Number | 95% Confidence Interval | Percentage of events/patients evaluated | Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study drug |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome | 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. Bleeding AEs=all serious or nonserious bleeding-related AEs. | All participants who received at least 1 dose of study drug | Posted | Number | Participants | Days 1 through 12 + 2 days (nonserious AEs, bleeding AES) or 30 days (SAES, deaths) after last dose of study drug |
|
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| Other Pre-specified | Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements) | preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal; abs=absolute. Hemoglobin (g/dL): >2 decrease from preRx value or value <=8; hematocrit (%): <0.75*preRx; platelets: <100*10^9 cells/L; erythrocytes (*10^6 cells/μL): <0.75*preRx; leukocytes: <0.75*LLN or >1.25*ULN, or if preRx <LLN, use <0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or <LLN; abs basophils: >400/mm^3; abs eosinophils: > 0.750*10^3 cells/µL; abs lymphocytes: <0.750*10*3 cells/ µL or >7.50*10^3 c/ µL; abs monocytes > 2000/mm^3; abs neutrophils: <1.0*10^3 cells/μL; ALP (U/L): >2*ULN; ALT, AST (U/L): >3*ULN; U/L; bilirubin, direct (mg/dL): >1.5*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN. | All participants who received at least 1 dose of study drug. n=number of participants with available measurements | Posted | Number | Participants | Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up |
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| Other Pre-specified | Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements) | preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRx<LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; chloride, serum (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx<LLN use <0.9*preRx or >ULN if preRx>ULN use >1.1*preRx or <LLN; bicarbonate (mEq/L): <0.75*LLN or >1.25*ULN, or if preRx < LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or < LLN; potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRx<LLN use <0.9 *preRx or >ULN if preRx>ULN use >1.1*preRx or <LLN; sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRx <LLN use <0.95*preRx or >ULN if preRx>ULN use >1.05*preRx or <LLN; protein, total (g/dL): <0.9*LLN or >1.1*ULN, or if preRx <LLN use 0.9*preRx or >ULN if preRx >ULN use 1.1*preRx or <LLN; CK (U/L): >5*ULN; uric acid (mg/dL): >1.5*ULN, or if preRx >ULN use >2*preRx; glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRx <LLN use <0.8*preRx or >ULN. | All participants who received at least 1 dose of study drug. n=number of participants with available measurements | Posted | Number | Participants | Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up |
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| Other Pre-specified | Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis) | preRX=pretreatment. Blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; glucose, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; protein, urine: If missing preRx use ≥ 2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; Red blood cells , urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; white blood cells, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4. | All participants who received at least 1 dose of study drug. n=number of participants with available measurements | Posted | Number | Participants | Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (± 5 days) of follow-up |
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Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Apixiban, 2.5 mg BID Plus Placebo | Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD) | 72 | 1,501 | 295 | 1,501 | ||
| EG001 | Enoxaparin, 40 mg QD Plus Placebo | Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID | 88 | 1,508 | 342 | 1,508 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Creatinine renal clearance decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypokinesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Suture related complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Wound haemorrhage | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Device dislocation | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Foreign body trauma | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Injection site extravasation | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Senile dementia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Wound sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Catheter related complication | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hepatic ischaemia | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | 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
| 65 years to younger than 75 years |
|
| 75 years and older |
|
| Male |
|
| Black/African American |
|
| Asian |
|
| Native Hawaiian/Other Pacific Islander |
|
| Other [Not specified] |
|
| Hispanic/Latino |
|
| Not Hispanic/Latino |
|
| Ethnicity not reported |
|
| Spain |
|
| Ukraine |
|
| Russian Federation |
|
| Israel |
|
| Chile |
|
| Colombia |
|
| Italy |
|
| India |
|
| France |
|
| Malaysia |
|
| Denmark |
|
| South Africa |
|
| China |
|
| Korea, Republic of |
|
| Austria |
|
| United Kingdom |
|
| Czech Republic |
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| Hungary |
|
| Mexico |
|
| Belgium |
|
| Brazil |
|
| Poland |
|
| Singapore |
|
| Norway |
|
| Germany |
|
| Sweden |
|
| Hip replacement |
|
| Hip or knee fracture surgery |
|
| Deep vein thrombosis |
|
| Pulmonary embolism |
|
| Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the secondary endpoint at a 1-sided α=0.025 level. If NI of the secondary endpoint was demonstrated, superiority was then tested at the 1-sided α=0.025 level. | Inverse variance method | Risk Difference (RD) | -1.04 | 95 | -2.03 | -0.05 | No | Superiority or Other |
Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
|
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| Participants |
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| OG001 | Enoxaparin, 40 mg QD + Placebo | Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID |
|
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