Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism (NCT01976507) | Clinical Trial Compass
CompletedPhase 4
Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism
United States101 participantsStarted 2013-10
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation.
Timeframe: Within 4 months following procedure (+/- 4 days)
2
Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation.
Timeframe: Within 4 months following procedure (+/- 4 days)