Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
Public ClinicalTrials.gov record NCT02164864. 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
A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) \<= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome). The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.
Study identification
- NCT ID
- NCT02164864
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,725 participants
Conditions and interventions
Interventions
- Dabigatran Etexilate 110mg Drug
- Warfarin 3mg Drug
- Aspirin Drug
- Dabigatran Etexilate 150mg Drug
- Clopidogrel or Ticagrelor Drug
- Warfarin 5mg Drug
- Warfarin 1mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Jul 22, 2014 (Actual)
- Primary completion
- Jun 5, 2017 (Actual)
- Completion
- Jun 5, 2017 (Actual)
- Last update posted
- Jul 31, 2018
2014 – 2017
United States locations
- U.S. sites
- 45
- U.S. states
- 24
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiology P.C. | Birmingham | Alabama | 35211 | — |
| Verde Valley Medical Center | Cottonwood | Arizona | 86326 | — |
| Cardiovascular Associates of Mesa | Mesa | Arizona | 85206 | — |
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | — |
| Arkansas Cardiology, PA | Little Rock | Arkansas | 72205 | — |
| Mission Cardiovascular Research Institute | Fremont | California | 94538 | — |
| Aurora Denver Cardiology Associates, PC | Aurora | Colorado | 80012 | — |
| University of Florida College of Medicine | Jacksonville | Florida | 32209 | — |
| Watson Clinic, LLP | Lakeland | Florida | 33805 | — |
| Community Clinical Research Center | Anderson | Indiana | 46011 | — |
| Midwest Cardiovascular Research and Education Foundation | Elkhart | Indiana | 46514 | — |
| Ball Memorial Hospital | Muncie | Indiana | 47303 | — |
| Richmond Cardiology Associates Research, LLC | Richmond | Indiana | 47374 | — |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Cape Cod Research Institute | Hyannis | Massachusetts | 02601 | — |
| Mid Michigan Medical Center | Midland | Michigan | 48670 | — |
| Covenant Medical Center, Inc. | Saginaw | Michigan | 48602 | — |
| Saint Mary's Medical Center dba Essentia Health Saint Mary's Medical Center | Duluth | Minnesota | 55805 | — |
| CentraCare Heart and Vascular Center | Saint Cloud | Minnesota | 56303 | — |
| Kansas City Veterans Administration Medical Center | Kansas City | Missouri | 64128 | — |
| Saint Anthony's Medical Center | St Louis | Missouri | 63128 | — |
| St. Michaels Medical Center | Newark | New Jersey | 07102 | — |
| Lourdes Cardiology Services | Voorhees Township | New Jersey | 08043 | — |
| VA Western New York Healthcare System | Buffalo | New York | 14215 | — |
| Novant Health Heart and Vascular Institute | Charlotte | North Carolina | 28204 | — |
| Altru Health System | Grand Forks | North Dakota | 58201 | — |
| Cardiovascular Research Center | Toledo | Ohio | 43608 | — |
| Chambersburg Hospital | Chambersburg | Pennsylvania | 17201 | — |
| Pinnacle Health Harrisburg Hospital | Harrisburg | Pennsylvania | 17101 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Chattanooga Heart Institute | Chattanooga | Tennessee | 37404 | — |
| The Jackson Clinic, PA | Jackson | Tennessee | 38301 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-8802 | — |
| Dallas VA Medical Center | Dallas | Texas | 75216 | — |
| North Dallas Research Associates | McKinney | Texas | 75069 | — |
| Scott and White Healthcare | Round Rock | Texas | 78665 | — |
| South Texas Cardiovascular Consultants | San Antonio | Texas | 78201 | — |
| Wichita Falls Heart Clinic | Wichita Falls | Texas | 76301 | — |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Bayview Physicians Services PC dba Cardiovascular Associates | Virginia Beach | Virginia | 23454 | — |
| Holy Family Memorial, Inc | Manitowoc | Wisconsin | 54220 | — |
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 376 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02164864, 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 Jul 31, 2018 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02164864 live on ClinicalTrials.gov.