drugset / Trial / NCT03684564
RIvaroxaban for Stroke Patients With AntiPhospholipid Syndrome
Phase 2
Completed
43 enrolled
University College, London
Barking, Havering and Redbridge University Hospitals NHS Trust · collabBarts & The London NHS Trust · collabEpsom and St Helier University Hospitals NHS Trust · collabHammersmith Hospitals NHS Trust · collabKing's College Hospital NHS Trust · collabUniversity College London Hospitals · collabVersus Arthritis · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Rivaroxaban versus warfarin for stroke patients with antiphospholipid syndrome, with or without SLE (RISAPS): a randomised, controlled, open-label, phase IIb, non-inferiority proof of principle trial. 40 patients will be randomised with a ratio of 1:1 to receive either: * Rivaroxaban 15mg twice daily orally for 24 months or * Warfarin (standard of care in the RISAPS trial) to maintain a target INR of 3.5 (range 3.0-4.0) for 24 months. The primary outcome of the trial is the rate of change in brain white matter hyperintensity (WMH) volume between baseline and 24 months follow up, assessed on brain magnetic resonance imaging (MRI), a surrogate marker of ischaemic damage.
Timeline
- Start
- 2021-07-09
- Primary completion
- 2025-07-31
- Completion
- 2025-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rivaroxaban | Other / unclassified | 15 mg | Oral |
| Comparator | Warfarin | Small molecule | — | Oral |