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

NCT ID: NCT02313584

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

464 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Atrial Fibrillation Thromboembolism

Keywords

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dabigatran

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Short Group

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

Group Type ACTIVE_COMPARATOR

dabigatran

Intervention Type DRUG

Conventional Group

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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dabigatran

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University

OTHER

Sponsor Role lead

Responsible Party

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Young-Hoon Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Young-Hoon Kim

Role: CONTACT

Phone: 82-2-920-6700

Email: [email protected]

Other Identifiers

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anam6394

Identifier Type: -

Identifier Source: org_study_id