UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment of paroxysmal atrial fibrillation with pill-in-the-pocket approach-comparison of propafenone and flecainide-
Title of the study (Brief title)	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	Yukio Ozaki
Organization	Fujita Health University School of Medicine
Division name	Department of Cardiology
Address	1-98 Dengakugakubo, Kutsukake-cho,
TEL	0562-9-2312
Email	enwatan@fujita-hu.ac.jp

Public contact
Name of contact person	Eiichi Watanabe
Organization	Fujita Health University School of Medicine
Division name	Department of Cardiology
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 10 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005441