RIvaroxaban for Stroke Patients With AntiPhospholipid Syndrome (RISAPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03684564|
Recruitment Status : Not yet recruiting
First Posted : September 25, 2018
Last Update Posted : September 25, 2018
RISAPS: Rivaroxaban versus warfarin for stroke patients with antiphospholipid syndrome, with or without SLE: a randomised, controlled, phase II/III, non-inferiority trial
140 patients will be randomised at a 1:1 to receive either
- rivaroxaban 15mg twice daily orally for 24 months or
- warfarin (as per standard care) to maintain a target INR of 3.5 (range 3.0-4.0) The primary outcome for the trial is the rate of change in brain white matter hyoerintensity (WMH) volume on MRI, a surrogate marker of ischaemic damage, assessed on the 3D FLAIR sequence, between baseline and 24 months follow up.
|Condition or disease||Intervention/treatment||Phase|
|Antiphospholipid Syndrome||Drug: Rivaroxaban Drug: Warfarin||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||October 2022|
rivaroxaban 15 mg twice daily orally for 24 months
rivaroxaban oral tablet twice daily for 24 months
Active Comparator: Warfarin (Standard of Care)
warfarin (as per standard of care) to maintain a target INR of 3.5 (range 3.0-4.0) for 24 months
warfarin (standard of care) to maintain a target INR of 3.5 (range 3.0 to 4.0)
- To compare the efficacy of high intensity oral rivaroxaban vs high intensity warfarin in patients with antiphospholipid syndrome with or without systemic lupus erythematosus who have had a stroke or other ischaemic brain manifestations. [ Time Frame: 24 months ]The comparison of efficacy will be based on the rate of change in brain white matter hyperintensity (WMH) volume on MRI, a surrogate marker of ischaemic damage, between baseline and 24 months follow up.
- Health Economics Analysis- cost per adjusted life year [ Time Frame: 24 months ]Mean incremental cost per quality adjusted life year (QALY) using responses on the five-level EQ-5D-5L completed at baseline and each follow-up visit.
- Clinical Measures of Efficacy- Vascular events [ Time Frame: 24 months ]
The following events defined and reported according to CTCAE v5
- Ischaemic stroke or transient ischaemic attack
- Occlusive arterial events in other sites including systemic embolism
- Cerebral venous thrombosis
- Venous thromboembolism in other sites
- Microvascular thrombosis
- Superficial venous thrombosis
- Clinical Measures of Efficacy- Death [ Time Frame: 24 months ]All reported deaths will be entered into the statistical model irrespective of the cause of death.
- A composite outcome measure of thrombotic events, including arterial, venous micro vascular and death. [ Time Frame: 24 months ]A composite outcome compiled of all reported thrombotic events and deaths during the trial as AEs or SAEs. All AEs & SAEs during the trial will be categorised using the CTCAE v5.
- Safety Events- bleeding all bleeds [ Time Frame: 24 months ]Bleeding: All bleeding events: major , clinically relevant or non-major , minor using the trial definitions for bleeding events
- Safety - All Serious Adverse Events [ Time Frame: 24 months ]Serious adverse events other than major bleeding using the criteria within the CTCAE version 5
- Safety- Cerebral Micro bleeds [ Time Frame: 24 months ]Cerebral microbleeds (CMB) assessed with susceptibility-weighted (SWI) imaging as a surrogate marker of bleeding risk
- Anti-coagulation intensity- Rivaroxaban anti-Xa levels [ Time Frame: 24 months ]Rivaroxaban anti-Xa levels
- Anti-coagulation intensity-Warfarin [ Time Frame: 24 months ]i) Time in target therapeutic range (TTR) ii) Amidolytic factor X as a lupus anticoagulant independent assessment of warfarin anticoagulant effect
- ii) Changes in total brain volume, white matter volume and grey matter volume on T1w volumetric images on MRI [ Time Frame: 24 Months ]This will be used as a marker for neurological efficacy of the IMP compared with current standard of care.
- Composite of clinical cardiac and cerebrovascular outcomes using MACCE [ Time Frame: 24 Months ]This will be a composite outcome analysis of all the cardiac and cerebrovascular events defined using MACCE reported on the trial
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684564
|Contact: RISAPS Trial Manager||020 7907 firstname.lastname@example.org|
|Principal Investigator:||Hannah Cohen||UCLH|