Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication ELIQUIS is a factor Xa inhibitor indicated: to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. FDA label
Apixaban · 1 trial · 1 indication
Freedom from death or hemocompatibility related adverse events (composite of stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism)
| Arm | Type | Description |
|---|---|---|
| Apixaban | EXPERIMENTAL | LVAD patients randomized to the experimental arm will be prescribed apixaban 5 mg twice daily. |
| Warfarin | ACTIVE_COMPARATOR | LVAD patients randomized to the control arm will be prescribed warfarin which will be dosed to achieve an INR goal of 2-2.5 |
| Name | Type | Description |
|---|---|---|
| Apixaban | DRUG | Patients randomized to apixaban will be started on a dose of 5 mg BID. |
| Warfarin | DRUG | Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. |
| LVAD implant | DEVICE | Subjects will undergo HeartMate 3 LVAD implant prior to randomization |
Inclusion Criteria: 1. Patients implanted with a HeartMate 3 LVAD 2. Age 18 or greater and able to provide written informed consent 3. Females of childbearing age must agree to adequate contraception Exclusion Criteria: 1. History of post-LVAD device thrombosis, stroke, or gastrointestinal bleedi...
Top 16 of 29 competitors