New indications for direct oral anticoagulants
| Indication . | NCT number . | Intervention . | Control . | Duration . | Sample size . | Efficacy outcome . | Safety outcome . |
|---|---|---|---|---|---|---|---|
| Arterial thrombosis | |||||||
| Embolic stroke of unknown source | RE-SPECT ESUS 02239120 | Dabigatran 150 or 110 mg BID | Aspirin | 3 y | 6000 | Recurrent stroke | Major bleeding |
| NAVIGATE ESUS 02313909 | Rivaroxaban 15 mg OD | Aspirin | 3 y | 7000 | Recurrent stroke or systemic embolism | Major bleeding | |
| Coronary or peripheral artery disease | COMPASS 01776424 | Rivaroxaban 5 mg BID or rivaroxaban 2.5 mg BID plus aspirin | Aspirin | 5 y | 27 000 | Major adverse cardiac events | Major bleeding |
| VOYAGER 02504216 | Rivaroxaban 2.5 mg BID on top of aspirin | Placebo on top of aspirin | 2 y | 6500 | Cardiovascular death, myocardial infarction, stroke, acute limb ischemia, or amputation | Major bleeding | |
| Venous thrombosis | |||||||
| Primary prevention | EPCAT II 01720108 | Rivaroxaban 10 mg OD | Aspirin | 10 or 30 d | 3426 | Symptomatic VTE | Major or clinically relevant nonmajor bleeding |
| Secondary prevention | EINSTEIN Choice 02064439 | Rivaroxaban 10 mg OD or rivaroxaban 20 mg OD | Aspirin | 1 y | 3399 | Recurrent VTE | Major bleeding |
| Indication . | NCT number . | Intervention . | Control . | Duration . | Sample size . | Efficacy outcome . | Safety outcome . |
|---|---|---|---|---|---|---|---|
| Arterial thrombosis | |||||||
| Embolic stroke of unknown source | RE-SPECT ESUS 02239120 | Dabigatran 150 or 110 mg BID | Aspirin | 3 y | 6000 | Recurrent stroke | Major bleeding |
| NAVIGATE ESUS 02313909 | Rivaroxaban 15 mg OD | Aspirin | 3 y | 7000 | Recurrent stroke or systemic embolism | Major bleeding | |
| Coronary or peripheral artery disease | COMPASS 01776424 | Rivaroxaban 5 mg BID or rivaroxaban 2.5 mg BID plus aspirin | Aspirin | 5 y | 27 000 | Major adverse cardiac events | Major bleeding |
| VOYAGER 02504216 | Rivaroxaban 2.5 mg BID on top of aspirin | Placebo on top of aspirin | 2 y | 6500 | Cardiovascular death, myocardial infarction, stroke, acute limb ischemia, or amputation | Major bleeding | |
| Venous thrombosis | |||||||
| Primary prevention | EPCAT II 01720108 | Rivaroxaban 10 mg OD | Aspirin | 10 or 30 d | 3426 | Symptomatic VTE | Major or clinically relevant nonmajor bleeding |
| Secondary prevention | EINSTEIN Choice 02064439 | Rivaroxaban 10 mg OD or rivaroxaban 20 mg OD | Aspirin | 1 y | 3399 | Recurrent VTE | Major bleeding |
BID, twice daily; COMPASS, Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease; EINSTEIN Choice, Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism; EPCAT II, Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty; NAVIGATE ESUS, Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source; NCT, national clinical trial (clinicaltirals.gov); OD, once daily; RE-SPECT ESUS, Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source; VOYAGER, Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities.