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NIH Stops Johnson & Johnson's Blood Thinner Drug Arm In Stroke Trial After Safety Review
Benzinga· 2026-02-11 19:23
Core Insights - The National Institutes of Health (NIH) has discontinued the low-dose rivaroxaban arm of the Phase 3 CAPTIVA stroke prevention trial due to safety concerns and lack of demonstrated benefit [1][2][3] Group 1: Trial Overview - The primary goal of the CAPTIVA trial is to assess whether rivaroxaban or ticagrelor, or both, are more effective than clopidogrel in reducing the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death [1][5] - The trial involves up to 1,683 participants across more than 100 sites over four years, as part of NIH's StrokeNet network [5] Group 2: Safety Review and Decision - An independent safety review by the Data Safety and Monitoring Board led to the decision to halt the rivaroxaban group due to increased safety events and a pre-specified futility threshold [2][3] - NIH emphasized that participant safety remains the top priority, and study sites have been instructed to stop administering the drug to participants in the discontinued arm [4] Group 3: Implications for Stroke Prevention - Rivaroxaban is an FDA-approved anticoagulant used for treating or preventing blood clots, and the discontinuation of this arm may impact future treatment strategies for stroke prevention [4][5] - The trial aims to generate additional safety and efficacy data while determining if either of the newer therapies offers an advantage over the current standard treatment [5]