Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

Completed · Phase 4

Conditions studied: Atrial Fibrillation, Atrial Flutter

In brief

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.

Key facts

Study ID: NCT01976507
Run by: Vanderbilt University Medical Center
People needed: 101
Starts: 2013-10-01
Expected to finish: 2016-12-01
Last updated by the study team: 2017-09-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female sex, age 18-85 years.
Negative pregnancy test for women of childbearing potential
Planned pulmonary vein isolation by antral radiofrequency or cryoablation for paroxysmal or persistent atrial fibrillation, non-valvular atrial fibrillation (NVAF), or left atrial flutter following prior left atrial ablation procedures
CHADS2 score of 0-6 or CHADS2-VASc score 0-9
Vascular hemostasis within 4-6 hours of sheath pull
Able to give informed consent

You may not qualify if…

Unable to give informed consent
Currently participating in another clinical treatment trial
History of hereditary hemophilias
Presence of active bleeding
End stage renal disease, CrCl<15 mL/min
Prior treatment failure of dabigatran (stroke or systemic thromboembolism while on therapeutic dabigatran)
Known allergic reaction to dabigatran etexilate
Intolerance to dabigatran, if medication naïve, or other contra-indications as per the USPI.
Pregnancy
History of non-compliance
Inability to follow-up

Where it is running

Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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