Table 1.

New indications for direct oral anticoagulants

IndicationNCT numberInterventionControlDurationSample sizeEfficacy outcomeSafety outcome
Arterial thrombosis
 Embolic stroke of unknown sourceRE-SPECT ESUS 02239120Dabigatran 150 or 110 mg BIDAspirin3 y6000Recurrent strokeMajor bleeding
NAVIGATE ESUS 02313909Rivaroxaban 15 mg ODAspirin3 y7000Recurrent stroke or systemic embolismMajor bleeding
 Coronary or peripheral artery diseaseCOMPASS 01776424Rivaroxaban 5 mg BID or rivaroxaban 2.5 mg BID plus aspirinAspirin5 y27 000Major adverse cardiac eventsMajor bleeding
VOYAGER 02504216Rivaroxaban 2.5 mg BID on top of aspirinPlacebo on top of aspirin2 y6500Cardiovascular death, myocardial infarction, stroke, acute limb ischemia, or amputationMajor bleeding
Venous thrombosis
 Primary preventionEPCAT II 01720108Rivaroxaban 10 mg ODAspirin10 or 30 d3426Symptomatic VTEMajor or clinically relevant nonmajor bleeding
 Secondary preventionEINSTEIN Choice 02064439Rivaroxaban 10 mg OD or rivaroxaban 20 mg ODAspirin1 y3399Recurrent VTEMajor 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.