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NCT02239120 · ClinicalTrials.gov registry record · Phase 3
Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
A Phase 3 study of Stroke and Secondary Prevention, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 5,390
- Enrollment target
- 20
- Study locations
NCT02239120: Completed Phase 3 study of Stroke and Secondary Prevention, sponsored by Boehringer Ingelheim.
NCT02239120 is a Phase 3 study of Stroke and Secondary Prevention that has completed, run by Boehringer Ingelheim. The registered enrollment target is 5,390 participants, below the 12,005-participant average among 454 other Stroke trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02239120, a Phase 3 study of Stroke and Secondary Prevention, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5,390 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Adjudicated recurrent stroke (ischemic, hemorrhagic, or unspecified) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.
Conditions Studied
Interventions
- DRUG optional ASA as comedication
- DRUG placebo to ASA
- DRUG placebo to optional ASA as comedication
- DRUG placebo to dabigatran etexilate
- DRUG ASA 100 mg
Study Locations (20)
California
- Westside Medical Associates of Los Angeles - Beverly Hills
- TriWest Research Associates, LLC - El Cajon
- University of California - Fresno
- Glendale Adventist Medical Center - Glendale
- Collaborative Neuroscience Network, LLC (CNS) - Long Beach
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- University of California Los Angeles - Los Angeles
- Huntington Hospital - Pasadena
- University of California - San Diego
- University of California - San Francisco
Colorado
- University of Colorado Denver - Aurora
- Colorado Neurological Institute - Englewood
- University of Colorado Denver - Fort Collins
- St. Mary's Hospital and Regional Medical Center - Grand Junction
Florida
- JEM Research Institute - Atlantis
- Boca Raton Regional Hospital - Boca Raton
- Tenet Florida Physician Services - Boynton Beach
- Nova Clinical Research, LLC - Bradenton
Arizona
- Bronislava Shafran, MD PC - Phoenix
Connecticut
- Hartford Hospital - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,390 participants |
| Start Date | 2014-11-27 |
| Est. Completion | 2018-08-14 |
| Phase | Phase 3 |
What the finished NCT02239120 record still lists
NCT02239120 is an interventional study that assigns participants to a tested intervention. Its 5,390 participants enrollment target places it among the larger protocols in the corpus, below the 12,005-participant average among 454 other Stroke trials with a reported enrollment target (55% lower).
The record links to 2 conditions, with Stroke appearing as the primary indexed condition, and to 5 interventions - of which optional ASA as comedication is the first listed.
NCT02239120 names 20 study sites across 5 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT02239120 about?
NCT02239120 is a clinical study titled "Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)". 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 corona...
What is the current status of trial NCT02239120?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,390 participants. The study started on 2014-11-27. Estimated completion is 2018-08-14.
What conditions does trial NCT02239120 study?
This clinical trial studies the following conditions: Stroke, Secondary Prevention.
What interventions are being tested in trial NCT02239120?
The interventions under investigation include: optional ASA as comedication (DRUG), placebo to ASA (DRUG), placebo to optional ASA as comedication (DRUG), placebo to dabigatran etexilate (DRUG), ASA 100 mg (DRUG).
Who is sponsoring clinical trial NCT02239120?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02239120 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02239120's enrollment target sits among peer trials
5,390 14th of 454 higher than 441 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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