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 (OTC:BAYRY) and Johnson & Johnson (NYSE:JNJ) as Xarelto.
What Does This Mean For Stroke Prevention?
Rivaroxaban is an FDA-approved anticoagulant used to treat or prevent blood clots. According to NIH, study sites with participants assigned to the discontinued arm have received instructions to stop the drug.
Individuals who completed the evaluation in that arm will be contacted by their respective study sites. NIH said participant safety remains its top priority.
The trial is designed to determine whether either of two newer treatment strategies is more effective than the current standard therapy in preventing recurrent stroke. Up to 1,683 participants are being enrolled across more than 100 sites over four years as part of NIH’s StrokeNet network.
Other treatment arms in the trial include:
AstraZeneca Plc’s (NASDAQ:AZN) Brilinta (ticagrelor) (180 mg loading dose, then 90 mg twice daily) plus aspirin (81 mg daily).
Sanofi SA’s (NASDAQ:SNY) Plavix (clopidogrel) (600 mg loading dose, then 75 mg daily) plus aspirin (81 mg daily)
The study will not directly compare the two newer therapies against each other. Instead, it aims to determine whether either offers an advantage over current treatment, while generating additional safety and efficacy data.
National Institute of Neurological Disorders and Stroke (NINDS) funds CAPTIVA and StrokeNet.
JNJ Price Action: Johnson & Johnson shares were up 1.09% at $240.95 at the time of publication on Wednesday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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