For people who have had a minor stroke or a transient ischemic stroke (TIA), combining the clot-preventing drug clopidogrel with aspirin may lower risk of having a major event within the next 90 days, new research shows.
A study of 4,881 adults in 10 countries who either had a minor stroke or a TIA showed that people who took clopidogrel plus aspirin had a 25 percent lower risk of a major stroke, heart attack, or death from blood clots within the three months after the first incident, compared with those who took aspirin alone.
Clopidogrel, known by the brand name Plavix, is a platelet inhibitor commonly prescribed to people who have peripheral artery disease or who have had a recent heart attack or stroke to prevent future events.
“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,” says lead author Clay Johnston, dean and professor of neurology at Dell Medical School at the University of Texas at Austin.
Both minor stroke and TIA are warning signs that a person has a 3 to 15 percent chance of having a more severe event within the next three months. Minor events result in mild, nondisabling symptoms.
TIA, often called a warning stroke or mini-stroke, is caused by a temporary blockage in a blood vessel to the brain that often dissolves or dislodges on its own to stop symptoms. More than a third of US adults have had TIA symptoms, according to the American Stroke Association.
The study, which appears in the New England Journal of Medicine, also showed a small increase in the risk of hemorrhage in the clopidogrel-aspirin group compared with the aspirin alone group.
For every 1,000 patients treated with the combination, an extra five major bleeds would be expected but with 15 fewer strokes and other major ischemic events. Because the bleeding events are generally reversible, the overall benefit outweighs the risk for most patients, Johnston says.
“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,” says coauthor Donald Easton, professor of neurology at the University of California, San Francisco School of Medicine.
Worth the risk
One previous trial in this area showed that clopidogrel plus aspirin was effective in lowering risks but did not find the risk of hemorrhage.
“The results of this large international trial, when added to the results of previous research, provide evidence to support the use of clopidogrel plus aspirin for 90 days among patients with minor ischemic stroke and high-risk TIA treated within 12 hours,” says Ralph Sacco, professor of neurology at Miller School of Medicine at the University of Miami. “This trial is likely to change practice since most clinicians and patients are usually willing to accept the increased risk of hemorrhage to offset the disabling impact of a stroke.”
The research is 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. It included patient information from 269 sites in 10 countries throughout North America, Europe, and Australia. Researchers included patients if they had a minor stroke or a transient ischemic stroke and were at high risk of having a major one.
“It’s likely we will see more patients who have had a TIA or a minor stroke receiving the combination of clopidogrel and aspirin in the future,” Johnston says. “If you’ve suffered from a minor stroke or TIA, it’s important to see a physician immediately, even in the emergency room, to ensure you’re taking steps to avoid a potentially debilitating stroke later on,” he says.
“There are several tests that need to be done right away to determine the cause of the event and to make sure the best treatments are started as soon as possible.”
The National Institute of Neurological Disorders and Stroke, which is part of the National Institutes of Health supported the POINT trial.
Source: University of Texas at Austin