At a Glance
- NIH discontinued the low-dose rivaroxaban arm of the CAPTIVA trial
- Increased safety events and evidence of futility triggered a pre-specified stopping rule
- Participants in the affected arm will stop treatment under site guidance
- The remaining ticagrelor and clopidogrel arms continue as planned
Written By: Pharmacally Medical News Desk
The National Institutes of Health (NIH) has halted one treatment arm of the CAPTIVA clinical trial after a routine safety evaluation identified concerns. Acting on a recommendation from the trial’s independent Data Safety and Monitoring Board (DSMB), NIH’s National Institute of Neurological Disorders and Stroke (NINDS) has discontinued the low-dose rivaroxaban regimen due to an observed increase in safety events and evidence of futility.
The CAPTIVA study, formally known as the Comparison of Anti-coagulation and Anti-platelet Therapies for Intracranial Vascular Atherostenosis, is designed to evaluate strategies for preventing recurrent stroke in high-risk patients. The DSMB determined that the low-dose rivaroxaban arm had reached a pre-specified stopping threshold, indicating that the treatment was unlikely to provide clinical benefit while raising safety concerns.
Rivaroxaban, an FDA-approved anticoagulant widely used for the treatment and prevention of blood clots, was being tested in combination with aspirin. Following the decision, all participating study sites received instructions to discontinue the drug in affected participants. Individuals who completed evaluations under the discontinued regimen will be contacted by their respective trial centers. NIH emphasized that participant safety remains the foremost priority. Importantly, the trial itself remains ongoing, with participants in the ticagrelor and clopidogrel arms continuing treatment as scheduled
CAPTIVA Trial
CAPTIVA (NCT05047172) is a large, double-blind randomized study evaluating strategies to prevent recurrent stroke in adults aged 30 years and older with severe intracranial arterial stenosis (70–99% narrowing of a major brain artery).
Participants were randomized to one of three treatment regimens:
- Ticagrelor plus aspirin
- Low-dose rivaroxaban plus aspirin (discontinued)
- Clopidogrel plus aspirin
All participants also receive intensive risk factor management and lifestyle coaching, with follow-up assessments conducted over one year.
The trial is designed to compare each investigational strategy against standard therapy rather than directly comparing the novel treatments.
Role of NIH and NINDS in the CAPTIVA Trial
The CAPTIVA trial is funded and overseen by the National Institute of Neurological Disorders and Stroke (NINDS), a component of the National Institutes of Health. NINDS plays a central role in supporting clinical research focused on the prevention and treatment of neurological disorders, including stroke. The CAPTIVA trial is being conducted through NIH’s StrokeNet network, supporting a large, multi-center study with planned enrolment of up to 1,683 participants across more than 100 sites in the United State.
Reference
NIH halts arm of clinical trial evaluating a potential stroke treatment, 10 February 2026, https://www.nih.gov/news-events/news-releases/nih-halts-arm-clinical-trial-evaluating-potential-stroke-treatment
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA), ClinicalTrials.gov ID NCT05047172, https://clinicaltrials.gov/study/NCT05047172
