NIH Discontinues Low-Dose Xarelto Arm in Phase 3 Stroke Trial
NIH discontinued the low-dose rivaroxaban arm of the Phase 3 CAPTIVA stroke prevention trial after an independent safety review flagged increased adverse events and a futility threshold. The halted arm, involving 1,683 patients at over 100 sites, delays Xarelto expansion in stroke therapy and may pressure Johnson & Johnson's pipeline.
1. NIH Halts Low-Dose Rivaroxaban Arm
The National Institutes of Health directed the discontinuation of the low-dose rivaroxaban arm of the Phase 3 CAPTIVA stroke prevention trial following a Data Safety and Monitoring Board review that identified increased adverse events and a prespecified futility threshold.
2. Scope and Design of CAPTIVA Trial
The CAPTIVA trial enrolls up to 1,683 participants across more than 100 sites, comparing rivaroxaban or ticagrelor arms against a clopidogrel plus aspirin control to assess stroke, hemorrhage, or vascular death outcomes at one year.
3. Potential Impact on Johnson & Johnson
Rivaroxaban, marketed as Xarelto by Johnson & Johnson and Bayer, faces a setback in its stroke prevention indication, potentially delaying revenue growth and raising concerns over the drug's late-stage clinical prospects.
4. Next Steps for Participants and Trial
Participants in the discontinued arm have been instructed to stop low-dose rivaroxaban, with study sites set to follow up on safety and transition plans, while the trial proceeds with the ticagrelor and clopidogrel arms.