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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004553
Receipt No. R000005441
Scientific Title Treatment of paroxysmal atrial fibrillation with pill-in-the-pocket approach-comparison of propafenone and flecainide-
Date of disclosure of the study information 2010/11/13
Last modified on 2017/05/19

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Basic information
Public title Treatment of paroxysmal atrial fibrillation with pill-in-the-pocket approach-comparison of propafenone and flecainide-
Acronym F-PITPA study
Scientific Title Treatment of paroxysmal atrial fibrillation with pill-in-the-pocket approach-comparison of propafenone and flecainide-
Scientific Title:Acronym F-PITPA study
Region
Japan

Condition
Condition Recent-onset atrial fibrillation
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compare the efficacy of propafenone and flecainide on the termination of recent-onset atrial fibrillation in Japanese
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Termination of atrial fibrillation within 120 min after treatment of propafenone or flecainide
Key secondary outcomes Safety (blood pressure and proarrhythmia)
Plasma drug concentration

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral loading of propafenon, 150 mg q.d.
Interventions/Control_2 Oral loading of flecainide,100 mg q.d.
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
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria The inclusion criteria were an age of 18 to 75 years, an episode of electrocardiographically documented atrial fibrillation of recent onset (less than 48 hours earlier), a mean heart rate of more than 70 beats per minute, and a systolic pressure of 100 mmHg or more.
Key exclusion criteria Patients were excluded if they had one or more of the following findings: electrocardiographic
evidence of ventricular pre-excitation or bundlebranch block (QRS interval >120 msec), a previous
episode of atrial fibrillation lasting seven days or more, ischemic heart disease, dilated or hypertrophic
cardiomyopathy, a history of heart failure, severe valvular heart disease, chronic cor pulmonale,
left ventricular dysfunction (ejection fraction, 50 percent), a long QT interval or the Brugada
syndrome, the bradycardia-tachycardia syndrome (resting heart rate, 50 beats per minute, or repetitive
sinoatrial blocks during waking hours), documentation of previous episodes of second or third-degree atrioventricular block, previous thromboembolic episodes, acute disease, very severe chronic diseases (e.g., muscular dystrophies or systemic collagen diseases), renal or hepatic insufficiency, previous hypokalemia (potassium level, <3 mmol per liter), suspected or known pregnancy, a known intolerance of flecainide or current propafenone, or current prophylactic antiarrhythmic treatment.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Ozaki
Organization Fujita Health University School of Medicine
Division name Department of Cardiology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho,
TEL 0562-9-2312
Email enwatan@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiichi Watanabe
Organization Fujita Health University School of Medicine
Division name Department of Cardiology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho,
TEL 0562-93-2312
Homepage URL
Email enwatan@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 藤田保健衛生大学病院

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2010 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 13 Day
Last modified on
2017 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005441

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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