Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
NCT02239120 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02239120
The ClinicalTrials.gov registry entry for NCT02239120 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02239120 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02239120?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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