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RIvaroxaban for Stroke Patients With AntiPhospholipid Syndrome

NCT03684564 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rivaroxaban

Oral tablet 15 mg twice daily for 24 months

DRUG

Warfarin

Oral anticoagulant given as standard of care in the RISAPS trial to maintain a target INR of 3.5 (range 3.0-4.0) for 24 months

Sponsors & Collaborators

  • University College London Hospitals

    collaborator OTHER

  • Barking, Havering and Redbridge University Hospitals NHS Trust

    collaborator OTHER

  • Hammersmith Hospitals NHS Trust

    collaborator OTHER

  • Epsom and St Helier University Hospitals NHS Trust

    collaborator OTHER

  • Barts & The London NHS Trust

    collaborator OTHER

  • King's College Hospital NHS Trust

    collaborator OTHER

  • Versus Arthritis

    collaborator OTHER

  • University College, London

    lead OTHER

Principal Investigators

  • Hannah Cohen · University College London Hospitals NHS Foundation Trust/University College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03684564 on ClinicalTrials.gov