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

Phase 3

• Conditions: Atrial Fibrillation; Thromboembolism
• Interventions: Drug: dabigatran; Drug: placebo

• Registration Number: NCT02313584
• Lead Sponsor: Korea University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-12
• Study Start: 2014-12
• Study First Submitted: 2014-12-07
• Study First Submitted QC: 2014-12-09
• Last Update Submitted: 2014-12-09
• Study First Posted: 2014-12-10
• Last Update Posted: 2014-12-10
• Primary Completion: 2016-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 464

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short Group	dabigatran	The patients taking dabigatran for 1 month after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.
Conventional Group	placebo	The patients taking dabigatran for 2 months after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.

Primary Outcome Measures

Name	Time	Method
The rate of thromboembolic events	2 months