NCT01775891

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

February 26, 2013

Status Verified

February 1, 2013

Enrollment Period

3 years

First QC Date

January 23, 2013

Last Update Submit

February 23, 2013

Conditions

Paroxysmal Atrial Fibrillation

Keywords

pilsicainideclass IC antiarrhythmic drugparoxysmal atrial fibrillationcatheter ablation

Outcome Measures

Primary Outcomes (1)

  • freedom from recurrence of any atrial arrhythmia within 1 year

    1 year

Study Arms (2)

pilsicainide

ACTIVE COMPARATOR

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: pilsicainideDrug: other class IC antiarrhythmic drug

other class IC antiarrhythmic drug

PLACEBO COMPARATOR

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: pilsicainideDrug: other class IC antiarrhythmic drug

Interventions

pilsicainideDRUG

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.

Also known as: Pilsicainide (Sunrhythm®) Daiichi Sankyo
other class IC antiarrhythmic drugpilsicainide
other class IC antiarrhythmic drugDRUG

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.

Also known as: flecainide 100mg bid PO or propafenone 225mg tid
other class IC antiarrhythmic drugpilsicainide

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arrhythmia center, Anam Hospital, Korea University

Seoul, 136-705, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

pilsicainideFlecainidePropafenone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropiophenonesKetonesOrganic Chemicals

Study Officials

  • Young-Hoon Kim, MD., PhD

    Arrhythmia center, Anam hospital, Korea university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young-Hoon Kim, M.D., PhD.

CONTACT

+82-10-9370-3337ypruimin@naver.com

Yae Min Park, M.D.

CONTACT

+82-10-9370-3337ypruimin@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. PhD

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 25, 2013

Study Start

July 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

February 26, 2013

Record last verified: 2013-02

Locations

KR(1)