Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism
This study is currently recruiting participants.
(see Contacts and Locations)
Verified June 2014 by Vanderbilt University
Sponsor:
Vanderbilt University
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Christopher Ellis, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01976507
First received: October 29, 2013
Last updated: June 26, 2014
Last verified: June 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Atrial Flutter |
Drug: dabigatran etexilate mesylate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- Frequency of major bleeding complications and thrombo-embolic events in patients administered dabigatran following RF ablation. [ Time Frame: Within 4 months following procedure (+/- 4 days) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Dabigatran serum drug levels in patients experiencing a major bleeding or thrombo-embolic event. [ Time Frame: Within 4 months following procedure (+/- 4 days) ] [ Designated as safety issue: Yes ]
- Frequency of minor bleeding events [ Time Frame: Within 4 months following procedure (+/- 4 days) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2013 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: dabigatran etexilate mesylate |
Drug: dabigatran etexilate mesylate
Other Name: Pradaxa
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01976507
Please refer to this study by its ClinicalTrials.gov identifier: NCT01976507
Contacts
| Contact: Sherry Bowman, RN | 615-875-5500 |
Locations
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Christopher Ellis, MD christopher.ellis@vanderbilt.edu | |
| Principal Investigator: Christopher R Ellis, MD | |
| Sub-Investigator: Sean P Whalen, MD | |
Sponsors and Collaborators
Vanderbilt University
Boehringer Ingelheim
Investigators
| Principal Investigator: | Christopher R Ellis, MD | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | Christopher Ellis, Assistant Professor of Medicine, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT01976507 History of Changes |
| Other Study ID Numbers: | 121204 |
| Study First Received: | October 29, 2013 |
| Last Updated: | June 26, 2014 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Dabigatran Anticoagulants |
Antithrombins Enzyme Inhibitors Hematologic Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Serine Proteinase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015