Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02164864 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
A Phase 3 study of Atrial Fibrillation and Percutaneous Coronary Intervention, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,725
- Enrollment target
- 20
- Study locations
NCT02164864 is a Phase 3 study of Atrial Fibrillation and Percutaneous Coronary Intervention that has completed, run by Boehringer Ingelheim. The registered enrollment target is 2,725 participants, roughly in line with the 2,983-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target. The trial reports 20 study locations across 11 states.
The verdict
NCT02164864, a Phase 3 study of Atrial Fibrillation and Percutaneous Coronary Intervention, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,725 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 2,725 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 2,983-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
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.
NCT02164864 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Indiana, Arizona, Massachusetts.
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.
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).
Who is sponsoring clinical trial NCT02164864?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Atrial Fibrillation
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.
-
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
RECRUITING · Phase 3
-
Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR
RECRUITING · Phase 3
-
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
RECRUITING · Phase 3
-
Semaglutide for Metabolic Intervention and Adipose Loss to Treat Atrial Fibrillation
RECRUITING · Phase 3
-
Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)
RECRUITING · Phase 3
-
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
RECRUITING · Phase 3
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.