UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004553 |
|---|---|
| Receipt number | 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 10:34:19 |
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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
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
enwatan@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005441
