You're now more up-to-date than your stroke medical 'professionals'
Study found low-dose rivaroxaban to be unsafe and ineffective compared to standard of care.The National Institutes of Health (NIH) has stopped an investigational treatment arm of the Comparison of Anti-coagulation and Anti-platelet Therapies for Intracranial Vascular Atherostenosis
(CAPTIVA) study following a regular review by the Data Safety and Monitoring Board (DSMB). The DSMB is an independent group of experts that regularly check if the study is safe. NIH’s National Institute of Neurological Disorders and Stroke, the trial’s funder, accepted the DSMB recommendation that CAPTIVA discontinue the low-dose rivaroxaban arm of the trial due to an increase in safety events and evidence of futility, a pre-specified stopping point to enable the study to end if early results showed the treatment is unlikely to help people. Rivaroxaban is a U.S. Food and Drug Administration-approved anticoagulant medication used to treat or prevent blood clots. All study sites that have active participants randomized to the discontinued arm have received instructions for drug discontinuation. Study participants who have completed their evaluation of the discontinued arm will be contacted by the site where they received treatment. Participant safety remains NIH’s top priority.The CAPTIVA study is a large, two-stage, double-blind randomized trial in participants age 30 and older with a stroke attributed to 70-99% narrowing, or stenosis, of a major intracranial artery. The study is testing whether either of two new treatments works better than the current treatment to prevent another stroke. The study, part of NIH’s
StrokeNet is in the midst of enrolling and evaluating up to 1,683 volunteers at over 100 study sites over a four-year period. Participants were randomized 1:1:1 to one year of treatment with:
- Ticagrelor (180 mg loading dose, then 90 mg twice daily) plus aspirin (81 mg daily)
- Low-dose rivaroxaban (2.5 mg twice daily) plus aspirin (81 mg daily)
- Clopidogrel (600 mg loading dose, then 75 mg daily) plus aspirin (81 mg daily)
In addition, participants will receive intensive risk factor management and lifestyle coaching. They will be evaluated at one month, four months, eight months, and one year after randomization into one of the study arms. At these intervals, participants will have their blood pressure checked, risk factors optimized and will be assessed for study outcomes.
CAPTIVA will not determine which new treatment is best. It will only show if either new treatment is better than what doctors currently use. Comparing the two new treatments directly would require many more patients. Nevertheless, CAPTIVA will provide important safety and efficacy data on both novel therapies.
The CAPTIVA Study and NIH’s StrokeNet are funded by NIH’s NINDS.
About the National Institute of Neurological Disorders and Stroke (NINDS): NINDS is the nation’s leading funder of research on the brain and nervous system. The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. https://www.ninds.nih.gov
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