Yale School of Medicine has received a 5-year, $20 million grant from the National Institute of Neurological Disorders and Stroke (NINDS) to administer a Phase III trial measuring the effectiveness of using a blood thinner to prevent new strokes in patients who suffered brain hemorrhages and have atrial fibrillation, or irregular heartbeat.
In collaboration with NINDS, part of the National Institutes of Health (NIH), the trial will be administered by the Department of Neurology at Yale and will include 700 survivors of brain hemorrhage who have atrial fibrillation. The subjects in the ASPIRE (Anticoagulation in Intracerebral Hemorrhage Survivors for Stroke Prevention and Recovery) trial will be recruited at 125 centers within the NIH StrokeNet system and receive either aspirin or the anticoagulant apixaban (Eliquis). NIH StrokeNet, comprised of 25 regional centers and more than 200 hospitals nationwide, serves as the pipeline for new potential treatments for people with stroke and those at risk for stroke. Blood thinners have shown to be effective in preventing the recurrence of ischemic stroke in which blood clots form in the brain, but it is still unclear whether they benefit stroke patients who have suffered severe brain bleeds.
Each year, more than 70,000 people in the U.S. experience brain hemorrhage.
“Currently, treatments for these patients are all over the map, which reflects uncertainty and the lack of data on this question,” says Kevin Sheth, MD, associate professor of neurology and of neurosurgery at Yale School of Medicine and co-principal investigator of the trial along with Cornell neurologist Hooman Kamel, MD. The trial will be one of the first to test stroke prevention measures in brain hemorrhage survivors.
The trial will also track individual risk profiles to better inform future treatments, Sheth says.
The trial is funded by NINDS grant 1U01NS106513.