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