The National Institutes of Health (NIH) on Tuesday discontinued the low-dose rivaroxaban arm of its ongoing Phase 3 CAPTIVA stroke prevention trial.

The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor, or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death.

The move follows an independent safety review that identified increased safety events and evidence that the treatment was unlikely to provide benefit.

NIH Halts Rivaroxaban Trial Amid Safety Concerns

The decision followed a routine evaluation by the study's Data Safety and Monitoring Board, an independent panel tasked with overseeing participant safety.

Based on its recommendation, NIH's National Institute of Neurological Disorders and Stroke, which funds the trial, directed that the rivaroxaban group be halted due to safety concerns and a pre-specified futility threshold.

Rivaroxaban is marketed by Bayer AG ...