Unique ID issued by UMIN | UMIN000006090 |
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Receipt number | 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 22:43:36 |
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
The multicenter study of rhythm-control drugs in patients with paroxysmal atrial fibrillation
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
The multicenter study of rhythm-control drugs in patients with paroxysmal atrial fibrillation
Japan |
Paroxysmal atrial fibrillation
Cardiology |
Others
NO
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
Efficacy
Number of days when atrial fibrillation is recorded on ambulatory electrocardiogram for a period of 5-12 weeks (treatment phase)
Time(days) to first documented atrial fiberillation after 4 weeks of dose finding period.
Quality of life (SF-36 score, AFQLQ score)
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Flecainide therapy
100-200mg daily
Pilsicainide therapy
75-225mg daily
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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.
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.
65
1st name | |
Middle name | |
Last name | Tsuyoshi Shiga |
Tokyo Women's Medical University
Cardiology
8-1 Kawada-cho, Shinjuku-ku, Tokyo
03-3353-8111
mshiga@hij.twmu.ac.jp
1st name | |
Middle name | |
Last name | Tsuyoshi Shiga |
Tokyo Women's Medical University
Cardiology
8-1 Kawada-cho, Shinjuku-ku, Tokyo
03-3353-8111
mshiga@hij.twmu.ac.jp
Steering committee in the multicenter study of rhythm-control drugs in patients with paroxysmal atrial fibrillation (Department of Cardiology, Tokyo Women's Medical University)
Japan Heart Foundation
Non profit foundation
Japan
NO
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)
2011 | Year | 08 | Month | 01 | Day |
Partially published
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.
Completed
2011 | Year | 07 | Month | 30 | Day |
2011 | Year | 08 | Month | 01 | Day |
2014 | Year | 03 | Month | 30 | Day |
2015 | Year | 02 | Month | 28 | Day |
2015 | Year | 03 | Month | 30 | Day |
2015 | Year | 07 | Month | 31 | Day |
2011 | Year | 08 | Month | 01 | Day |
2016 | Year | 08 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007196
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