Austin, TX—A new study on what medication therapy should be prescribed after patients experience a small stroke or transient ischemic attack (TIA) is predicted to be practice-changing.

The research, published in the New England Journal of Medicine and presented at the 4th European Stroke Organization Conference in Gothenburg, Sweden, involved an international clinical trial of more than 4,880 participants in 10 countries. It concluded that combining clopidogrel and aspirin decreased risk of a new stroke, heart attack or other ischemic event within 90 days for those patients.

The University of Texas medical school–led study cautioned, however, that the therapy was not without risks. Results indicate the combination therapy was associated with an increase in major bleeding, although the episodes were nonfatal and generally didn’t occur in the brain.

Results indicated that minor stroke/TIA survivors who took clopidogrel in addition to aspirin had a 25% lower risk of a major stroke, heart attack, or death from blood clots within the 3 months after the first incident, compared with those who took aspirin alone.

“The study gives us solid evidence that we can use this drug combination to prevent strokes in the highest-risk people, but not without some risk of bleeding,” explained lead author Clay Johnston, MD, PhD, Dean and Professor of Neurology at Dell Medical School at The University of Texas at Austin.

After a minor stroke or TIA, patients are considered to have an elevated risk of 3% to 15% of suffering a more severe stroke. Even with the increased hemorrhage risk—an extra five major bleeds would be expected for every 1,000 patients treated with the combo, although most are reversible—the benefits appear to outweigh the risk for most patients, Johnston points out in a University of Texas press release.

 “Of the 33 major hemorrhages that occurred in these 4,881 patients, more than half involved the gastrointestinal tract, and none of them was fatal. These largely preventable or treatable bleeding complications of the treatment have to be balanced against the benefit of avoiding disabling strokes,” added co-author Donald Easton, MD. The therapy is calculated to prevent 15 strokes per 1,000 patients, the study notes.

The research was part of the Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) trial, a randomized, double-blind, placebo-controlled trial conducted between May 2010 and December 2017. 

The POINT trial was supported by the National Institute of Neurological Disorders and Stroke (NINDS), which is part of the National Institutes of Health. 

“These findings are likely to have a global effect on clinical practice, as these drugs are easily available in many hospitals and clinics,” emphasized Walter Koroshetz, MD, director of NINDS. “As the benefit of the combination was concentrated in the first two 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).”

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