Lead Investigator: Aristeidis Katsanos, Hamilton Health Sciences Corporation
Title of Proposal Research: Individual Participant Data Meta-Analysis of Randomized Trials of Anticoagulation compared to Antiplatelet Therapy in Patients with Embolic Strokes of Undetermined Source
Vivli Data Request: 9774
Funding Source: None
Potential Conflicts of Interest: Dr. Diener reports: PI of the RESPECT-ESUS trial. This will be acknowledged in all presentations and publications of the individual patient data meta-analysis. Dr. Shoamanesh reports: Project officer for the NAVIGATE-ESUS trial. This will be acknowledged in all presentations and publications of the individual patient data meta-analysis. Dr. Hart reports: PI of the NAVIGATE-ESUS trial. This will be acknowledged in all presentations and publications of the individual patient data meta-analysis.
Summary of the Proposed Research:
A stroke occurs when there is a problem with the blood supply to the brain. It can happen when a blood vessel carrying oxygen and nutrients to the brain is either blocked by a clot (a mass formed by the clumping together of blood cells and proteins) or bursts. As a result, part of the brain doesn’t get the blood and oxygen it needs, which can lead to damage or even death of brain cells. Globally, one in four people over age 25 will have a stroke in their lifetime. Up to one in four of strokes occur from blood clots that travel to the brain without an apparent source or cause. These types of strokes are called “Embolic Strokes of Undetermined Source” (ESUS).
We know that it is very frequent for people after an ESUS to have another stroke. Researchers have done four different studies to see if using stronger blood thinners (anticoagulation) is better than milder blood thinning medication (aspirin) at preventing another stroke in people with ESUS. These studies have not show that anticoagulation is better than aspirin in patients with ESUS.
We think that although anticoagulants might not help everyone with ESUS, they might be helpful for selected groups of people with ESUS. However, the number of people in the individual trials are not large enough to allow exploring this question in a reliable fashion. We propose combining data from these four studies (total of about 13,943 participants) to be able to answer this question in a more reliable way. Our proposed research may help identify people with ESUS that could benefit from stronger blood thinners.
Requested Studies:
Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)
Data Contributor: Boehringer Ingelheim
Study ID: NCT02239120
Sponsor ID: 1160.189