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Efficacy of Pilsicainide After Radiofrequency Ablation of Paroxysmal Atrial Fibrillation

This study is currently recruiting participants.
Verified February 2013 by Korea University
Sponsor:
Information provided by (Responsible Party):
Young-Hoon Kim, Korea University
ClinicalTrials.gov Identifier:
NCT01775891
First received: January 23, 2013
Last updated: February 23, 2013
Last verified: February 2013
History of Changes
  Purpose

Investigators hypothesized that the use of Pilsicainide after radiofrequency ablation of AF could reduce the incidence of recurrence of atrial arrhythmia during follow up compared with other class IC antiarrhythmic drugs.


Condition Intervention
Paroxysmal Atrial Fibrillation
 Drug: pilsicainide
Drug: other class IC antiarrhythmic drug

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Pilsicainide After Radiofrequency Ablation of Paroxysmal Atrial Fibrillation Compared With Other Class IC Anti-arrhythmic Drugs

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Korea University:

Primary Outcome Measures:
  • freedom from recurrence of any atrial arrhythmia within 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 245
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pilsicainide
The dose of pilsicainide will be 50mg tid PO. Pilsicainide will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
 Drug: pilsicainide
The dose of pilsicainide will be 50mg tid PO. Pilsicainide will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
Other Name: Pilsicainide (Sunrhythm®) Daiichi Sankyo
Drug: other class IC antiarrhythmic drug
Other class IC antiarrhythmic drug that they had been taking before catheter ablation will be administrated.(flecainide 100mg bid PO or propafenone 225mg tid) Antiarrhythmic drug will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
Other Name: flecainide 100mg bid PO or propafenone 225mg tid
Placebo Comparator: other class IC antiarrhythmic drug
Other class IC antiarrhythmic drug that they had been taking before catheter ablation will be administrated.(flecainide 100mg bid PO or propafenone 225mg tid) Antiarrhythmic drug will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
 Drug: pilsicainide
The dose of pilsicainide will be 50mg tid PO. Pilsicainide will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
Other Name: Pilsicainide (Sunrhythm®) Daiichi Sankyo
Drug: other class IC antiarrhythmic drug
Other class IC antiarrhythmic drug that they had been taking before catheter ablation will be administrated.(flecainide 100mg bid PO or propafenone 225mg tid) Antiarrhythmic drug will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
Other Name: flecainide 100mg bid PO or propafenone 225mg tid

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with drug-refractory paroxysmal atrial fibrillation who requires catheter ablation
  • patients who are aged 18-80 and agree with this study

Exclusion Criteria:

  • patients who do not agree with this study
  • patients with a history of catheter ablatio or surgery for atrial fibrillation
  • patients who experienced side effects of pilsicainide before
  • patients who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • patients who has congestive heart failure with ejection fraction<40% or decompensated heart failure
  • patients with significant coronary artery disease, liver/renal disease
  • patients who has other kinds of arrhythmic which requires active treatment
  • contraindication to warfarin therapy
  • life expectancy <1 year]
  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775891

Contacts
Contact: Young-Hoon Kim, M.D., PhD. +82-10-9370-3337 ypruimin@naver.com
Contact: Yae Min Park, M.D. +82-10-9370-3337 ypruimin@naver.com

Locations
Korea, Republic of
Arrhythmia center, Anam Hospital, Korea University Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Young-Hoon Kim, M.D. PhD.     +82-10-9370-3337     ypruimin@naver.com    
Contact: Yae Min Park, M.D.     +82-10-9370-3337     ypruimin@naver.com    
Sponsors and Collaborators
Korea University
Investigators
Principal Investigator: Young-Hoon Kim, MD., PhD Arrhythmia center, Anam hospital, Korea university
  More Information

No publications provided

Responsible Party: Young-Hoon Kim, M.D. PhD, Korea University
ClinicalTrials.gov Identifier: NCT01775891     History of Changes
Other Study ID Numbers: PIL245
Study First Received: January 23, 2013
Last Updated: February 23, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Korea University:
pilsicainide
class IC antiarrhythmic drug
paroxysmal atrial fibrillation
catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Pilsicainide
Anti-Arrhythmia Agents
Propafenone
Flecainide
Lidocaine
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013