NCT02239120

Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,390 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 150 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Stroke
• Secondary Prevention

Interventions

Type	Name	Description
DRUG	optional ASA as comedication	optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.
DRUG	placebo to ASA	placebo to comparator drug
DRUG	placebo to optional ASA as comedication	optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.
DRUG	placebo to dabigatran etexilate	placebo
DRUG	ASA 100 mg	active comparator drug
DRUG	dabigatran etexilate	active drug

Timeline

• Start date: 2014-11-27
• Primary completion: 2018-08-14
• Completion: 2018-08-14
• First posted: 2014-09-12
• Last updated: 2019-09-06
• Results posted: 2019-09-06

Locations

569 sites across 42 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Peru, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine