CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 101 enrolled
Drug / intervention
dabigatran etexilate mesylatedrug
Likely dose
dabigatran etexilate mesylate 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/NCT01976507
NCT01976507Phase 4Completed
CompareCT.gov

Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism in Patients Undergoing Left Atrial Catheter Ablation Procedures for Paroxysmal or Persistent (Non-permanent) Atrial Fibrillation and Left Atrial Flutter

Vanderbilt University Medical Center·interventional·Posted Nov 5, 2013·Updated Sep 12, 2017

In Brief

A Phase 4 clinical trial evaluating dabigatran etexilate mesylate for Atrial Fibrillation and Atrial Flutter. Completed, enrolled 101 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate major adverse bleeding risks, and thromboembolic event rates post radiofrequency (RF) ablation. The primary goal is to establish safety of dabigatran use for peri-procedural anti-coagulation after left atrial catheter radiofrequency ablation, or cryoablation procedures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Atrial Flutter
CountriesUnited States
CollaboratorsBoehringer Ingelheim

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 5, 2013
Enrollment StartOct 1, 2013
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.7 years ago

Interventions

dabigatran etexilate mesylatedrug

Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.