Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Apixaban · 3 trials · 4 indications
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.
Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.
| Arm | Type | Description |
|---|---|---|
| Apixaban | EXPERIMENTAL | - |
| UFH/Warfarin | ACTIVE_COMPARATOR | - |
| Apixaban 5mg BID | EXPERIMENTAL | - |
| Apixaban 2.5mg BID | EXPERIMENTAL | - |
| Warfarin | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | Period I: fasting state, Period II: fed state |
| 2 | EXPERIMENTAL | Period I: fed state, Period II: fasting state |
| 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 |
| Warfarin sodium | DRUG | At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks |
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...
Apixaban is an investigational small molecule being studied for use in atrial fibrillation, deep vein thrombosis, and pulmonary embolism. It has been evaluated in clinical trials enrolling healthy volunteers and patients with these cardiovascular conditions. The drug is being developed by Pfizer, Inc.
Apixaban is a small molecule that targets factor Xa, an enzyme involved in blood coagulation. By inhibiting factor Xa, it reduces thrombin generation and blood clot formation. This mechanism is relevant for conditions like atrial fibrillation and deep vein thrombosis, where preventing clots is a therapeutic goal.
Apixaban is being developed by Pfizer, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the safety and efficacy of Apixaban in cardiovascular indications.
Apixaban is in Phase 2 clinical development. A Phase 2 study in atrial fibrillation has been completed, along with a Phase 1 food effect study and a Phase 3 study in Japanese patients with deep vein thrombosis and pulmonary embolism. The drug is investigational and not yet approved.
Apixaban has been studied in several completed trials. NCT00787150 is a Phase 2 study in atrial fibrillation with 222 participants. NCT01437839 is a Phase 1 food effect study in healthy volunteers with 22 participants. NCT01780987 is a Phase 3 study in Japanese patients with deep vein thrombosis and pulmonary embolism with 80 participants.
Apixaban is the generic name for the drug marketed as Eliquis. Eliquis is the brand name used for apixaban in approved indications. In clinical development, the drug is referred to as apixaban, and it is being studied for cardiovascular conditions like atrial fibrillation and deep vein thrombosis.