September 30, 2015International Journal of Stroke
Design of Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate vs. Acetylsalicylic Acid in Patients with Embolic Stroke of Undetermined Source (Re-Spect Esus)
Key result
The RE-SPECT ESUS trial is designed to determine if dabigatran is superior to acetylsalicylic acid for preventing recurrent stroke in 6,000 patients with embolic stroke of undetermined source.
Why the study?
Does dabigatran etexilate reduce recurrent stroke in patients with embolic stroke of undetermined source compared to acetylsalicylic acid?
Population
Approximately 6000 patients with embolic stroke of undetermined source, enrolled within three-months after…
Comparison
Dabigatran etexilate treated for an expected… vs Acetylsalicylic acid.
Design
Randomized, Double-blind
Follow-up
Minimum of six-months and up to approximately three-years
Authors
Discussion
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Implication
Seeks to resolve anticoagulation debate in ESUS; extends randomized NOAC data beyond documented AF.
Key Points
- To determine whether the direct thrombin inhibitor dabigatran etexilate is superior to acetylsalicylic acid for secondary stroke prevention and to characterize its safety profile in patients with embolic stroke of undetermined source.
- Prospective, randomized, double-blind, multicenter trial enrolling approximately 6,000 patients across 550 centers within three months of an embolic stroke of undetermined source.
- Participants are randomized to dabigatran etexilate or acetylsalicylic acid and treated for an expected minimum of six months up to approximately three years.
- Event-driven design powered to observe 353 adjudicated primary outcome events.
- The primary efficacy endpoint assesses time to first recurrent stroke across ischemic, hemorrhagic, and unspecified categories.
- Key secondary efficacy endpoints evaluate time to first ischemic stroke alongside a composite outcome of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death.
- The primary safety outcome monitors major hemorrhage, specifically capturing incidences of symptomatic intracranial hemorrhage.
Study Design
Type
RCT (n=6,000)
Blinding
Double-blind
Randomization
randomized
Multicenter
Yes
Structured PICO
Does dabigatran etexilate reduce recurrent stroke in patients with embolic stroke of undetermined source compared to acetylsalicylic acid?
P
Population
Approximately 6,000 patients with embolic stroke of undetermined source, randomized within 3 months of stroke and followed for 6 months to 3 years.
I
Intervention
Dabigatran etexilate (oral thrombin inhibitor) treated for an expected minimum of six-months and up to approximately three-years.
C
Comparator
Acetylsalicylic acid.
O
Outcome
Time to first recurrent stroke (ischemic, hemorrhagic, or unspecified).hard clinical
The RE-SPECT ESUS trial is designed to determine if dabigatran is superior to acetylsalicylic acid for secondary stroke prevention in patients with embolic stroke of undetermined source.
Cite This Study
Diener et al. (2015) conducted an RCT in Embolic stroke of undetermined source (n=6,000). Dabigatran etexilate vs. Acetylsalicylic acid was evaluated on Time to first recurrent stroke (ischemic, hemorrhagic, or unspecified). The RE-SPECT ESUS trial is designed to determine if dabigatran is superior to acetylsalicylic acid for preventing recurrent stroke in 6,000 patients with embolic stroke of undetermined source.