Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
Public ClinicalTrials.gov record NCT02239120. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02239120
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 5,390 participants
Conditions and interventions
Conditions
Interventions
- 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
- dabigatran etexilate Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 150 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 27, 2014 (Actual)
- Primary completion
- Aug 14, 2018 (Actual)
- Completion
- Aug 14, 2018 (Actual)
- Last update posted
- Sep 6, 2019
2014 – 2018
United States locations
- U.S. sites
- 110
- U.S. states
- 36
- U.S. cities
- 97
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Bronislava Shafran, MD PC | Phoenix | Arizona | 85006 | — |
| Westside Medical Associates of Los Angeles | Beverly Hills | California | 90211 | — |
| TriWest Research Associates, LLC | El Cajon | California | 92020 | — |
| University of California | Fresno | California | 93721 | — |
| Glendale Adventist Medical Center | Glendale | California | 91206 | — |
| Collaborative Neuroscience Network, LLC (CNS) | Long Beach | California | 90806 | — |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| Huntington Hospital | Pasadena | California | 91105 | — |
| University of California | San Diego | California | 92103 | — |
| University of California | San Francisco | California | 94143 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| Colorado Neurological Institute | Englewood | Colorado | 80113 | — |
| University of Colorado Denver | Fort Collins | Colorado | 80528 | — |
| St. Mary's Hospital and Regional Medical Center | Grand Junction | Colorado | 81501 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| JEM Research Institute | Atlantis | Florida | 33462 | — |
| Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | — |
| Tenet Florida Physician Services | Boynton Beach | Florida | 33472 | — |
| Nova Clinical Research, LLC | Bradenton | Florida | 34209 | — |
| Broward Health North | Deerfield Beach | Florida | 33064 | — |
| Center for Advanced Research Excellence | Hialeah | Florida | 33016 | — |
| Bruce W. Carter, Miami VA Healthcare System | Miami | Florida | 33125 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Bay Neurological Institute | Panama City | Florida | 32405 | — |
| Carol L Pappas, MD PhD PA | St. Petersburg | Florida | 33713 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| Vero Beach Neurology and Research Institute | Vero Beach | Florida | 32960 | — |
| Palm Beach Neuroscience Institute | West Palm Beach | Florida | 33409 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| WellStar Medical Group - Neurosurgery | Marietta | Georgia | 30060 | — |
| The Queen's Medical Center | Honolulu | Hawaii | 96813 | — |
| Saint Alphonsus Medical Center-Neurology | Boise | Idaho | 83704 | — |
| Northwest Heart Clinical Research, LLC | Arlington Heights | Illinois | 60005 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Medicoricium, LLC | Fairview Heights | Illinois | 62208 | — |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Quincy Physicians and Surgeons Clinic, S.C. | Quincy | Illinois | 62301 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| Community Clinical Research Center | Anderson | Indiana | 46011 | — |
| Ruan Neurology Clinic and Research Center | Des Moines | Iowa | 50314 | — |
| Associates in Neurology, PSC | Lexington | Kentucky | 40513 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Alexandria Cardiology Clinic | Alexandria | Louisiana | 71301 | — |
| Culicchia Neurological Clinic | Marrero | Louisiana | 70072 | — |
| Tulane University Hospital and Clinic | New Orleans | Louisiana | 70112 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| McLaren Flint | Flint | Michigan | 48532 | — |
| Mercy Health Saint Mary's | Grand Rapids | Michigan | 49503 | — |
| Spectrum Health Medical Center | Grand Rapids | Michigan | 49503 | — |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | — |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341 | — |
| The Duluth Clinic dba Essentia Health Duluth Clinic | Duluth | Minnesota | 55805 | — |
| Abbott Northwestern Hospital, Radiology Department | Minneapolis | Minnesota | 55407 | — |
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | 55130 | — |
| Jackson Heart Clinic, P.A. | Jackson | Mississippi | 39216 | — |
| Boone Hospital Center | Columbia | Missouri | 65201 | — |
| University of Missouri Health System | Columbia | Missouri | 65201 | — |
| SSM Health St. Clare Hospital | Fenton | Missouri | 63026 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Saint Louis University | St Louis | Missouri | 63104 | — |
| St. Louis Heart and Vascular, P.C. | St Louis | Missouri | 63136 | — |
| The Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Renown Institute for Neurosciences | Reno | Nevada | 89502 | — |
| NYC Health + Hospitals/Coney Island | Brooklyn | New York | 11235 | — |
| New York Presbyterian Hudson Valley Hospital | Cortlandt Manor | New York | 10567 | — |
| UHS Wilson Medical Center,Office of Clin Trials | Johnson City | New York | 13790 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| Mount Sinai Beth Israel | New York | New York | 10003 | — |
| Novant Health Neurology Specialists | Charlotte | North Carolina | 28207 | — |
| Duke Clinic 1L | Durham | North Carolina | 27710 | — |
| Cone Health System | Greensboro | North Carolina | 27401 | — |
| Novant Health Neurology Hickory | Hickory | North Carolina | 28602 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Altru Health System | Grand Forks | North Dakota | 58201 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Holzer Clinic LLC | Gallipolis | Ohio | 45631 | — |
| Advanced Neurology Associates | Youngstown | Ohio | 44504 | — |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | — |
| Veterans Affairs Portland Health Care System | Portland | Oregon | 97239 | — |
| Sacred Heart Medical Center at RiverBend | Springfield | Oregon | 97477 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| Abington Neurological Associates | Willow Grove | Pennsylvania | 19090 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Greenville Memorial Hospital | Greenville | South Carolina | 29605 | — |
| Methodist University Hospital | Memphis | Tennessee | 38105 | — |
| Centennial Heart Cardiovascular Consultants, LLC | Nashville | Tennessee | 37203 | — |
| Saint Thomas Health | Nashville | Tennessee | 37205 | — |
| Seton Medical Center Austin | Austin | Texas | 78705 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Bhupesh Dihenia, M.D.,P.A. | Lubbock | Texas | 79410 | — |
| University of Vermont | Burlington | Vermont | 05401 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Carilion Riverside | Roanoke | Virginia | 24016 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| Swedish Neuroscience Institute | Seattle | Washington | 98122 | — |
| Marshall University | Huntington | West Virginia | 25701 | — |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 459 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02239120, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 6, 2019 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02239120 live on ClinicalTrials.gov.