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

Korea University

Status and phase: Unknown; Phase 3

Conditions: Thromboembolism; Atrial Fibrillation

Treatments: Drug: placebo; Drug: dabigatran

Study type: Interventional

Funder types: Other

Identifiers

NCT02313584

anam6394

Details and patient eligibility

About

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.

Enrollment: 464 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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464 participants in 2 patient groups, including a placebo group

Short Group

Active Comparator group

Description:

The patients taking dabigatran for 1 month after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.

Treatment:

Drug: dabigatran

Conventional Group

Placebo Comparator group

Description:

The patients taking dabigatran for 2 months after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.

Treatment:

Drug: placebo