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Updated: Jun 17, 2025

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation

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Rivaroxaban for stroke patients with antiphospholipid syndrome (RISAPS): protocol for a randomized controlled, phase

Prabal Mittal^1,2, Rafael Gafoor³, Zara Sayar^1,4

¹Department of Haematology, University College London Hospitals NHS Foundation Trust, London, United Kingdom.

Research and Practice in Thrombosis and Haemostasis

|August 14, 2024

Summary

High-dose rivaroxaban may be a safe and effective alternative to warfarin for secondary stroke prevention in antiphospholipid syndrome (APS). Further trials are needed to confirm these findings in APS patients.

Keywords:

antiphospholipid syndrome ischemic stroke rivaroxaban thrombosis warfarin

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Published on: October 12, 2012

Area of Science:

Cardiology
Neurology
Hematology

Background:

Antiphospholipid syndrome (APS) patients with ischemic stroke require optimal secondary prevention, but current therapies like warfarin have limitations.
Direct oral anticoagulants (DOACs) offer potential advantages over warfarin for APS patients.
The optimal antithrombotic strategy for APS-associated ischemic events remains undefined.

Purpose of the Study:

To investigate if high-dose rivaroxaban is a safe and effective alternative to high-intensity warfarin for secondary prevention in APS patients.
To compare the efficacy and safety of rivaroxaban versus warfarin in adults with APS and prior ischemic brain injury.
To provide proof-of-principle for future larger trials on DOACs in APS.

Main Methods:

A phase IIb, randomized, controlled, noninferiority trial comparing rivaroxaban 15 mg twice daily to warfarin (INR target 3.0-4.0).
The primary efficacy endpoint is the change in brain white matter hyperintensity volume over 24 months.
Secondary and exploratory outcomes include additional clinical and radiological measures, and pharmacokinetic modeling.

Main Results:

The study is designed to assess noninferior efficacy and safety of high-dose rivaroxaban compared to warfarin.
Results will inform the design of larger, definitive randomized controlled trials.
The trial focuses on a specific subgroup of APS patients with prior ischemic brain manifestations.

Conclusions:

If the RISAPS trial demonstrates noninferiority, it will support further investigation into high-dose rivaroxaban for APS.
This study could pave the way for a new standard of care in secondary prevention for APS patients.
The findings may lead to expanded use of DOACs in managing APS-related cerebrovascular events.