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| ID | Type | Description | Link |
|---|---|---|---|
| CV185160 | Other Identifier | BMS |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total treatment period is 24 weeks)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban | Experimental |
| |
| UFH/Warfarin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | 10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Bleeding Events ï¼»Per International Society on Thrombosis and Homeostasis (ISTH) Definitionï¼½ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period | Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ï¼»Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)ï¼½ or VTE-Related Death During the Intended Treatment Period | VTE-related death was defined as a death caused by documented PE which was diagnosed with objective testing or autopsy, or an unexplained death for which DVT/PE could not be ruled out as the cause. "Intended Treatment Period" was the period starting on the day of randomization and ending at either 2 days after the last dose of the study drug or Day 168/Week 24, whichever came late. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Medical University Hospital | Nagakute | Aichi-ken | 480-1195 | Japan | ||
| Toho University Sakura Medical Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Apixaban | Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks. |
| FG001 | Unfractionated Heparin (UFH)/Warfarin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Unfractionated Heparin (UFH) |
| Drug |
Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more |
|
| Warfarin | Drug | Dosing for 24 weeks to target INR range between 1.5-2.5 |
|
| Baseline to Week 24 |
| Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) | Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24. | Baseline to Week 24 |
| Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE) | Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24. | Baseline to Week 24 |
| Number of Participants With Adjudicated Major Bleeding Events ï¼»Per International Society on Thrombosis and Homeostasis (ISTH) Definitionï¼½During the Treatment Period | Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. | Baseline to Week 24 |
| Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods | All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis ï¼»ISTHï¼½ Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding. | Baseline to Week 24 |
| Sakura |
| Chiba |
| 285-8741 |
| Japan |
| Kokura Memorial Hospital | Kitakyushu | Fukuoka | 802-8555 | Japan |
| Fukushima Medical University Hospital | Fukushima | Fukushima | 960-1295 | Japan |
| Hiroshima General Hospital | Hatsukaichi | Hiroshima | 738-8503 | Japan |
| Teine Keijinkai Hospital | Sapporo | Hokkaido | 006-8555 | Japan |
| Kanazawa Medical University Hospital | Kahoku-gun | Ishikawa-ken | 920-0293 | Japan |
| Yokohama Minami Kyousai Hospital | Yokohama | Kanagawa | 236-0037 | Japan |
| National Hospital Organization Yokohama Medical Center | Yokohama | Kanagawa | 245-8575 | Japan |
| Kumamoto University Hospital | Kumamoto | Kumamoto | 860-8556 | Japan |
| Saiseikai Kumamoto Hospital | Kumamoto | Kumamoto | 861-4193 | Japan |
| Mie University Hospital | Tsu | Mie-ken | 514-8507 | Japan |
| National Hospital Organization Okayama Medical Center | Okayama | Okayama-ken | 701-1192 | Japan |
| Kinki University Hospital | Sayama | Osaka | 589-8511 | Japan |
| National Cerebral and Cardiovascular Center Hospital | Suita-shi | Osaka | 565-8565 | Japan |
| St. Luke's International Hospital | Chuo-ku | Tokyo | 104-8560 | Japan |
| Nihon University Itabashi Hospital | Itabashi-ku | Tokyo | 173-8610 | Japan |
| National Hospital Organization Tokyo Medical Center | Meguro-ku | Tokyo | 152-8902 | Japan |
| Japanese Red Cross Musashino Hospital | Musashino | Tokyo | 180-8610 | Japan |
| Tokyo Medical University Hospital | Shinjuku-ku | Tokyo | 160-0023 | Japan |
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants including one participant who was assigned to the UFH/Warfarin group and withdrew from the study prior to receiving any study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Apixaban | Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks. |
| BG001 | Unfractionated Heparin (UFH)/Warfarin | UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks. |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Primary Diagnosis, Deep Venous Thrombosis (DVT)/Pulmonary Embolism (PE) | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Major Bleeding Events ï¼»Per International Society on Thrombosis and Homeostasis (ISTH) Definitionï¼½ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period | Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. | The safety analysis set (SAS) consisted of all treated participants. | Posted | Number | participants | Baseline to Week 24 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ï¼»Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)ï¼½ or VTE-Related Death During the Intended Treatment Period | VTE-related death was defined as a death caused by documented PE which was diagnosed with objective testing or autopsy, or an unexplained death for which DVT/PE could not be ruled out as the cause. "Intended Treatment Period" was the period starting on the day of randomization and ending at either 2 days after the last dose of the study drug or Day 168/Week 24, whichever came late. | Full analysis set (FAS) was defined as all randomized participants. Participants with missing endpoint information were excluded from the analysis. | Posted | Number | participants | Baseline to Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) | Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24. | A subset of full analysis set (FAS) that consisted of participants with DVT. n=number of participants evaluated. | Posted | Number | participants | Baseline to Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE) | Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24. | A subset of full analysis set (FAS) that consisted of participants with PE. n=number of participants evaluated. | Posted | Number | participants | Baseline to Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adjudicated Major Bleeding Events ï¼»Per International Society on Thrombosis and Homeostasis (ISTH) Definitionï¼½During the Treatment Period | Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. | The safety analysis set (SAS) consisted of all treated participants. | Posted | Number | participants | Baseline to Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods | All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis ï¼»ISTHï¼½ Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding. | The safety analysis set (SAS) consisted of all treated participants. | Posted | Number | participants | Baseline to Week 24 |
|
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The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Apixaban | Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks. | 3 | 40 | 29 | 40 | ||
| EG001 | Unfractionated Heparin (UFH)/Warfarin | UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks. | 7 | 39 | 34 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Thalamus haemorrhage | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Clinical Trials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_inquiries@pfizer.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 |
|---|---|
| C522181 | apixaban |
| D006493 | Heparin |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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| PE |
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| Units | Counts |
|---|---|
| Participants |
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| Units |
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| Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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