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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006090
Receipt No. R000007196
Scientific Title The multicenter study of rhythm-control drugs in patients with paroxysmal atrial fibrillation: Comparison of the efficacy of flecainide or pilsicainide in patients with symptomatic paroxysmal atrial fibrillation
Date of disclosure of the study information 2011/08/01
Last modified on 2016/08/05

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Basic information
Public title The multicenter study of rhythm-control drugs in patients with paroxysmal atrial fibrillation: Comparison of the efficacy of flecainide or pilsicainide in patients with symptomatic paroxysmal atrial fibrillation
Acronym The multicenter study of rhythm-control drugs in patients with paroxysmal atrial fibrillation
Scientific Title The multicenter study of rhythm-control drugs in patients with paroxysmal atrial fibrillation: Comparison of the efficacy of flecainide or pilsicainide in patients with symptomatic paroxysmal atrial fibrillation
Scientific Title:Acronym The multicenter study of rhythm-control drugs in patients with paroxysmal atrial fibrillation
Region
Japan

Condition
Condition Paroxysmal atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare flecainide and pilsicainide in terms of preventive effect of recurrences of atrial fibrillation and influence on quality of life in patients with symptomatic paroxysmal atrial fibrillation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of days when atrial fibrillation is recorded on ambulatory electrocardiogram for a period of 5-12 weeks (treatment phase)
Key secondary outcomes Time(days) to first documented atrial fiberillation after 4 weeks of dose finding period.
Quality of life (SF-36 score, AFQLQ score)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Flecainide therapy
100-200mg daily
Interventions/Control_2 Pilsicainide therapy
75-225mg daily
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1:History of symptomatic paroxysmal atrial fibrillation of a frequency of two or more attacks per month, and paroxysmal atrial fibrillation was previously indentified by electrocardiography when patient complained symptom.
2:Presence of sinus rhythm before the start of the study.
3. Patients who gave written informed consent to participate.
Key exclusion criteria 1. Patients with obvious structural heart disease.
2. Potentially dangerous symptoms associated with paroxysmal atrial fibrillation, such as syncope and transient ischemic attacks.
3. History of cerebral vascular accident associated with occurrence of paroxysmal atrial fibrillation.
4. Excessive bradycardia (<40 bpm) or sick sinus syndrome.
5. PR interval 0.28 or more second, second or third degree atrioventricular block, bundle branch block, severe intraventricular conduction delay.
6. Implantation of pacemaker or implantable cardioverter-defibrillator.
7. Paroxysmal atrial fibrillation caused by reversible, noncardiac disease such as hyperthyroidism.
8. Requirement of ongoing therapy with other antiarrhythmic drug.
9. Significant serious noncardiac disease such as hepatic, renal, hematological and lung diseases.
10. Pregnancy or possibility of pregnancy, and breast feeding.
11. Judgement by attending physician that patient participation would be inappropriate.
Target sample size 65

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Shiga
Organization Tokyo Women's Medical University
Division name Cardiology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email mshiga@hij.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Shiga
Organization Tokyo Women's Medical University
Division name Cardiology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Homepage URL
Email mshiga@hij.twmu.ac.jp

Sponsor
Institute Steering committee in the multicenter study of rhythm-control drugs in patients with paroxysmal atrial fibrillation (Department of Cardiology, Tokyo Women's Medical University)
Institute
Department

Funding Source
Organization Japan Heart Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京女子医科大学病院(東京都)
(財)心臓血管研究所病院(東京都)
藤田保健衛生大学病院(愛知県)
国立病院機構大阪医療センター(大阪府)
岩手医科大学病院(岩手県)
大阪大学病院(大阪府)
大分大学病院(大分県)
東海大学病院(神奈川県)
東邦大学医療センター大森病院(東京都)
岡山大学病院(岡山県)
聖マリアンナ医科大学病院(神奈川県)
京都大学病院(京都府)
長崎大学病院(長崎県)
群馬大学病院(群馬県)
東京女子医科大学東医療センター(東京都)
日本大学板橋病院(東京都)
翔南病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There was no significant difference in main outcome(days/8weeks)between flecainide and pilsicainide treatments.
There was no significant difference in first recurrence of PAF during the efficacy phase between both treatments. 
Scores of AFQLQ 1 and 2 (AF related symptoms) increased from baseline to treatment periods.
There were no significant differences in QOL scores (AFQLQ, SF-36) between both treatments. 
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2014 Year 03 Month 30 Day
Date of closure to data entry
2015 Year 02 Month 28 Day
Date trial data considered complete
2015 Year 03 Month 30 Day
Date analysis concluded
2015 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 08 Month 01 Day
Last modified on
2016 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007196

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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