CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 678 enrolled
Drug / intervention
Warfarin +1 moredrug
Likely dose
Dabigatran Etexilate 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02348723
NCT02348723Phase 4Completed
CompareCT.gov

Randomized Evaluation of Dabigatran Etexilate Compared to warfarIn in pulmonaRy Vein Ablation: Assessment of an Uninterrupted periproCedUral alntIcoagulation sTrategy (The RE-CIRCUIT Trial)

Boehringer Ingelheim·interventional·Posted Jan 28, 2015·Updated Jan 29, 2018

In Brief

A Phase 4 clinical trial evaluating Warfarin and Dabigatran Etexilate 150mg for Atrial Fibrillation. Completed, enrolled 678 participants across 87 sites in 11 countries.

Detailed Summary

The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study. Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting. It is not intended to assess confirmatory hypothesis, this is an exploratory study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesBelgium, Canada, France, Germany, Italy, Japan, Netherlands, Russia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 28, 2015
Enrollment StartApr 28, 2015
Primary CompletionNov 11, 2016
Study CompletionNov 14, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.4 years ago

Interventions

Warfarindrug

Patients receiving Warfarin to keep International Normalized Ratio (INR)between 2.0 - 3.0

Dabigatran Etexilate 150mgdrug

Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID)