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

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ClinicalTrials.gov Identifier: NCT02313584
Recruitment Status : Unknown
Verified December 2014 by Young-Hoon Kim, Korea University Anam Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 10, 2014
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
Young-Hoon Kim, Korea University Anam Hospital

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Thromboembolism Drug: dabigatran Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 464 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : December 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017


Arm Intervention/treatment
Active Comparator: Short Group
The patients taking dabigatran for 1 month after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.
Drug: dabigatran
Placebo Comparator: Conventional Group
The patients taking dabigatran for 2 months after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.
Drug: placebo



Primary Outcome Measures :
  1. The rate of thromboembolic events [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313584


Contacts
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Contact: Young-Hoon Kim 82-2-920-6700 yhkmd@unitel.co.kr

Sponsors and Collaborators
Korea University

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Responsible Party: Young-Hoon Kim, Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT02313584    
Other Study ID Numbers: anam6394
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014
Keywords provided by Young-Hoon Kim, Korea University Anam Hospital:
dabigatran
Additional relevant MeSH terms:
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Atrial Fibrillation
Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants