At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating optional ASA as comedication, placebo to ASA, and 4 other interventions for Stroke and Secondary Prevention. Completed, enrolled 5,390 participants across 569 sites in 42 countries.
Detailed Summary
This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).
Study Details
Timeline
Interventions
optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.
placebo to comparator drug
optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.
placebo
active comparator drug
active drug