RIvaroxaban for Stroke Patients With AntiPhospholipid Syndrome
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Rivaroxaban Versus Warfarin for Stroke Patients With Antiphospholipid Syndrome, With or
Without SLE (RISAPS): a Randomised, Controlled, Open label, Phase II/III, Non-inferiority
Trial.
140 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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University College, London
Collaborators:
Arthritis Research UK Barking, Havering and Redbridge University Hospitals NHS Trust Barts & The London NHS Trust Guy's and St Thomas' NHS Foundation Trust Hammersmith Hospitals NHS Trust King's College Hospital NHS Trust King's College London Manchester University NHS Foundation Trust St George's University Hospitals NHS Foundation Trust University College London Hospitals