Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01780987 | AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients | PHASE3 | COMPLETED | 80 | — | — | Jan 1, 2013 | Sep 1, 2014 | Jun 23, 2016 | 20 | Japan |
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.
| Arm | Type | Description |
|---|---|---|
| Apixaban | EXPERIMENTAL | - |
| UFH/Warfarin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Apixaban | DRUG | 10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks) |
| 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 |
Inclusion Criteria: * Acute symptomatic proximal DVT with evidence of proximal thrombosis * Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches Exclusion Criteria: * Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA. * Unco...