RIvaroxaban for Stroke patients with AntiPhospholipid Syndrome
Research type
Research Study
Full title
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
IRAS ID
248593
Contact name
Hannah Cohen
Contact email
Sponsor organisation
University College London
Eudract number
2018-001735-49
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 0 days
Research summary
The RISAPS trial follows on from the RAPS (Rivaroxaban in Antiphospholipid Syndrome) study that showed that rivaroxaban offers an effective alternative to warfarin for patients with APS who have thrombosis (blood clots) in their veins, rather than in their arteries and require standard intensity anticoagulation (blood thinning).
Currently, APS patients who have had an ischaemic stroke (which occurs when blood flow to an area of brain is cut off) are treated with warfarin to reduce the risk of a recurrence. Warfarin tends to have a variable ‘blood thinning’ effect in patients with APS, necessitating frequent (usually weekly) INR blood tests to monitor the effect of the warfarin, which is inconvenient for patients.
The RISAPS trial will compare higher intensity (higher dose) rivaroxaban versus higher intensity warfarin (current standard of care treatment) for 24 months, in APS patients, with or without lupus, requiring higher intensity anticoagulation after experiencing a stroke, a 'mini stroke' (also known as a transient ischaemic attack) or other ischaemic brain damage (caused by blood clots in the brain arteries or smaller blood vessels). Rivaroxaban, unlike warfarin, does not require regular blood tests, because it has a more predictable blood thinning effect. Furthermore, rivaroxaban does not interact with food or alcohol and has fewer interactions with other drugs.
If rivaroxaban is no worse than warfarin for anticoagulation of APS patients with stroke, it could become the standard of care for the treatment of APS patients, with or without lupus, who have experienced stroke or other ischaemic brain damage and improve patients' quality of life. The more predictable blood thinning effect of rivaroxaban may also be associated with a lower risk of bleeding and thrombosis than in patients on warfarin.
The RISAPS trial is funded by the registered charity Versus Arthritis (formerly known as Arthritis Research UK).
REC name
London - Dulwich Research Ethics Committee
REC reference
19/LO/0201
Date of REC Opinion
25 Feb 2019
REC opinion
Favourable Opinion