Grant: Project Grant

Stroke is the 3rd leading cause of death and primary cause of disability globally. One of the most common causes of stroke is from narrowing of the brain arteries from cholesterol plaques. Currently, when someone has this type of a stroke they are treated with aspirin, blood pressure management and cholesterol-lowering medication to prevent another stroke. However, even with these treatments, there is a high risk of having another stroke (1 in 20 chance in 30 days and 1 in 10 chance at one year). In patients with narrowing of arteries from cholesterol plaque in elsewhere in the body (heart and limbs), by adding low-dose rivaroxaban (blood thinner) to aspirin, there was a 50% reduction of stroke without an increase in brain or fatal bleeding. We plan to assess efficacy and safety of low-dose rivaroxaban and aspirin in preventing recurrent strokes in those with stroke secondary to narrowing of brain arteries. To test this hypothesis we did a pilot study in this population to assess enrolment feasibility and safety. We were able to finish the study ahead of time and no safety concerns were identified. The study results were published in Stroke (a leading journal in stroke) in January 2025. Our goal is to enrol 1172 participants and randomly assign them to the combination treatment or aspirin. For the first phase of the study we will assess any safety concerns and efficacy after 586 participants are recruited and followed up for at least 6 months. At this time if necessary we will re-calculate sample size. Patients will qualify to be in the study if they are over 40 years and has a stroke or transient ischemic attack (warning stroke) due to narrowing of the brain arteries by plaque. Patients will be followed for an average of 18 months. If this combination is eventually confirmed to reduce stroke by 30%, with comparable safety to currently used antiplatelet therapy (aspirin) it would be the biggest advance in stroke prevention in the past 30 years.