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Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)

NCT02348723 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 678

Last updated 2018-01-29

Study results available
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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.

Conditions

Interventions

DRUG

Warfarin

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

DRUG

Dabigatran Etexilate 150mg

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-28
Primary Completion
2016-11-11
Completion
2016-11-14

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02348723 on ClinicalTrials.gov