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Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
NCT02164864 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Aspirin
- DRUG Dabigatran Etexilate 110mg
- DRUG Warfarin 3mg
- DRUG Dabigatran Etexilate 150mg
- DRUG Clopidogrel or Ticagrelor
Study Locations (20)
Indiana
- Community Clinical Research Center — Anderson
- Midwest Cardiovascular Research and Education Foundation — Elkhart
- Ball Memorial Hospital — Muncie
- Richmond Cardiology Associates Research, LLC — Richmond
Arizona
- Verde Valley Medical Center — Cottonwood
- Cardiovascular Associates of Mesa — Mesa
- HonorHealth Research Institute — Scottsdale
Massachusetts
- Massachusetts General Hospital — Boston
- Brigham and Women's Hospital — Boston
- Cape Cod Research Institute — Hyannis
Florida
- University of Florida College of Medicine — Jacksonville
- Watson Clinic, LLP — Lakeland
Michigan
- Mid Michigan Medical Center — Midland
- Covenant Medical Center, Inc. — Saginaw
Alabama
- Cardiology P.C. — Birmingham
Arkansas
- Arkansas Cardiology, PA — Little Rock
California
- Mission Cardiovascular Research Institute — Fremont
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,725 participants |
| Start Date | 2014-07-22 |
| Est. Completion | 2017-06-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02164864
The ClinicalTrials.gov registry entry for NCT02164864 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 2,725 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 Atrial Fibrillation appearing as the primary indexed condition, and to 5 interventions — of which Aspirin 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: NCT02164864 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Indiana, Arizona, Massachusetts. 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 NCT02164864 about?
NCT02164864 is a clinical study titled "Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)". 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 Antit...
What is the current status of trial NCT02164864?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,725 participants. The study started on 2014-07-22. Estimated completion is 2017-06-05.
What conditions does trial NCT02164864 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Percutaneous Coronary Intervention. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02164864?
The interventions under investigation include: Aspirin (DRUG), Dabigatran Etexilate 110mg (DRUG), Warfarin 3mg (DRUG), Dabigatran Etexilate 150mg (DRUG), Clopidogrel or Ticagrelor (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02164864?
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 NCT02164864 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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