Investigation on Appropriate Duration of Dabigatran Use After Catheter Ablation for Paroxysmal Atrial Fibrillation in Patients With Low Thromboembolic Risk

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02313584
• Other study ID #: anam6394
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 7, 2014
• Last updated: December 9, 2014
• Start date: December 2014
• Est. completion date: September 2017

Study information

• Verified date: December 2014
• Source: Korea University
• Contact: Young-Hoon Kim
• Phone: 82-2-920-6700
• Email: yhkmd[@]unitel.co.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the appropriate duration of dabigatran use after radiofrequency catheter ablation for paroxysmal atrial fibrillation in patients with low thromboembolic risk. According to the most recent guideline, anticoagulation is recommended to continue at least 2 months after the procedure. However bleeding risk with anticoagulant is also problematic. Post-procedural thrombosis is considered due to acute inflammation or char formation at the site of ablation, and these reaction occurs mostly within 1 month after the procedure. Also, the risk of thromboembolism is low in patients with CHA2DS2-VASc score less than 1. The investigators hypothesized that dabigatran use for the first 1 month after the RFCA for patients with paroxysmal AF and low thromboembolic risk would be sufficient for efficacy and safety compared to conventional dabigatran use for 2 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 464
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• paroxysmal AF undergoing catheter ablation

• CHA2DS2-VASc score <= 1

• informed consent

Exclusion Criteria:

• persistent AF

• CHA2DS2-VASc score > 2

• prior CVA

• prior atnicoagulant

• severe HF

• abnormal liver or renal function

• history of severe bleeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Thromboembolism

Intervention

Drug:
• dabigatran

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of thromboembolic events		2 months	Yes