Trial | Design | Patient Population | Intervention | Comparison | Primary Outcome | Results/ ECD |
---|---|---|---|---|---|---|
RAPS (NCT02116036) | Prospective, controlled, phase 2/3, non-inferiority RCT | Primary or secondary thrombotic APS with previous isolated venous thromboembolism | Rivaroxaban 20 mg once daily | Warfarin (INR 2.0–3.0) | Endogenous thrombin potential (ETP) | Rivaroxaban did not reach the non-inferiority threshold |
TRAPS (NCT02157272) | Phase 3, open-label, multicenter, non-inferiority RCT with blinded end-point | Triple positive thrombotic APS patients | Rivaroxaban 20 mg once daily (CrCl> 50) or 15 mg daily (if CrCl 30–50) | Warfarin (INR 2.0–3.0) | Cumulative incidence of thromboembolic events, major bleeding and vascular death | Terminated prematurely due to an excess of events in rivaroxaban arm |
ASTRO-APS (NCT02295475) | Prospective, open-label, blinded event, phase 4 pilot RCT | Primary or secondary thrombotic APS. Exclusion: previous arterial events and recurrent venous thromboembolism when taking warfarin with INR of 2.0–3.0. | Apixaban 2.5 mg twice a day (increased to 5 mg twice a day + brain MRI after protocol modification) | Warfarin (INR 2.0–3.0) | Rates of thrombosis and deaths caused by thrombosis/ major bleeding plus clinically relevant non-major bleeding over 1 year | Protocol modification (2017): unanticipated excessive risk of arterial events during the first months in apixaban group. |
ECD: December 2019. | ||||||
Canadian RAPS (NCT02116036) | Pilot phase 4, open-label RCT | Primary or secondary thrombotic APS (history of arterial thrombosis allowed). Exclusion: arterial thrombosis or recurrent venous events while on anticoagulation. | Rivaroxaban 20 mg daily | None (single-arm) | Rates of venous and arterial thrombosis and rates of minor, major and fatal bleeding | Single-arm feasibility study; |
Rates of thrombosis similar to warfarin studies | ||||||
NCT02926170 | Prospective, open-label, phase 3 RCT | APS patients with previous arterial events and recurrent thrombosis | Rivaroxaban 20 mg once daily (CrCl> 50) or 15 mg daily (if CrCl 30–50) | Acenocoumarol (INR 2.0 to 3.0 or 2.5 to 3.5 if recurrent thrombosis) | New thrombotic event or incidence of major bleeding (time frame: 36 months) | Rivaroxaban did not reach the non-inferiority threshold |
RISAPS (NCT03684564) | Prospective, controlled, phase 2/3, non-inferiority RCT | Primary or secondary thrombotic APS with previous stroke or other ischemic brain manifestations | Rivaroxaban 15 mg twice a day | Warfarin (INR between 3.0–4.0) | Rate of chance in brain white matter hyperintensity volume on MRI (baseline and 24 months) | ECD: October 2022 |