NIH Halts Rivaroxaban Arm in 1,683-Patient Phase 3 Stroke Trial on Safety Concerns
The NIH has discontinued the low-dose rivaroxaban arm in its Phase 3 CAPTIVA stroke prevention trial after an independent safety review flagged increased safety events and futility. The trial continues with AstraZeneca’s Brilinta plus aspirin and Sanofi’s Plavix plus aspirin arms across over 100 sites enrolling up to 1,683 participants.
1. Discontinuation of Rivaroxaban Arm
An independent Data Safety and Monitoring Board review identified increased safety events and a pre-specified futility threshold, prompting the NIH’s National Institute of Neurological Disorders and Stroke to halt the low-dose rivaroxaban group in the Phase 3 CAPTIVA trial.
2. Ongoing Brilinta and Plavix Arms
The CAPTIVA trial continues with two experimental arms: AstraZeneca’s Brilinta (ticagrelor 180 mg loading dose then 90 mg twice daily plus 81 mg aspirin) and Sanofi’s Plavix (clopidogrel 600 mg loading dose then 75 mg daily plus 81 mg aspirin), across over 100 sites.
3. Trial Objectives and Design
CAPTIVA aims to enroll up to 1,683 participants over four years to compare newer antithrombotic strategies against standard clopidogrel plus aspirin, measuring one-year rates of ischemic stroke, intracerebral hemorrhage or vascular death.