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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: Completed Phase 3 study of Atrial Fibrillation and Percutaneous Coronary Intervention, sponsored by Boehringer Ingelheim.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported. Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation peri

Conditions Studied

Atrial Fibrillation Percutaneous Coronary Intervention

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

FieldValue
Enrollment Target 2,725 participants
Start Date 2014-07-22
Est. Completion 2017-06-05
Phase Phase 3
Boehringer Ingelheim

515 total trials

What the finished NCT02164864 record still lists

NCT02164864 is an interventional study that assigns participants to a tested intervention. Its 2,725 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 2,983-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target.

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 names 20 study sites across 11 states, led by 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.

Where NCT02164864's enrollment target sits among peer trials

2,725 24th of 202 higher than 179 of 202 other Atrial Fibrillation trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02164864, the US trial registry maintained by the National Library of Medicine. NCT02164864 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.