International Study Suggests Combination Therapy May Prevent Stroke in Certain People
Results from an international clinical trial of more than 4,880 participants, published in the New England Journal of Medicine, show that combining clopidogrel and aspirin following a small stroke or minor stroke symptoms decreases risk of a new stroke, heart attack or other ischemic event within 90 days. The combination therapy was also associated with an increase in major bleeding, although many of those episodes were non-fatal and did not occur in the brain. The study was supported by NINDS.
“These findings are likely to have a global effect on clinical practice, as these drugs are easily available in many hospitals and clinics,” said NINDS director Dr. Walter Koroshetz. “As the benefit of the combination was concentrated in the first 2 weeks while risk of bleeding was constant over 90 days, it may be especially valuable in acute management of a minor ischemic stroke or transient ischemic attack [TIA].”
The Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) clinical trial follows an earlier study, which showed benefits of this drug combination in a Chinese population. POINT was conducted to see whether the benefits could be expanded to a more diverse group of patients.
The study, led by Dr. S. Claiborne Johnston of Dell Medical School at the University of Texas at Austin, included patients who had experienced either a minor stroke or a TIA, in which blood supply to a part of the brain is briefly stopped and can be a risk factor for a larger stroke. Study participants were given clopidogrel and aspirin or aspirin alone to see whether the combination therapy could prevent a larger stroke within 3 months.
Johnston’s team found that the combination of clopidogrel and aspirin prevented more ischemic events, such as stroke and heart attack, compared to aspirin alone. The results showed that 5 percent of patients in the combination therapy group and 6.5 percent of patients taking only aspirin experienced such an event within 90 days.
However, the combination therapy was associated with a greater risk of major bleeding, or hemorrhage, than aspirin alone.
“We saw a real benefit with the combination therapy, but that treatment does come with a risk,” said Johnston. “Overall, the risk of severe bleeding was very small, but it was not zero.”
The study was stopped early because the combination therapy was found to be more effective than aspirin alone in preventing severe strokes but also due to the risk of severe hemorrhage.