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Treatment of paroxysmal atrial fibrillation with pill-in-the-pocket approach-comparison of propafenone and flecainide-

Treatment of paroxysmal atrial fibrillation with pill-in-the-pocket approach-comparison of propafenone and flecainide- - F-PITPA study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004553
Enrollment
50
Registered
2010-11-13
Start date
2010-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recent-onset atrial fibrillation

Interventions

Oral loading of propafenon, 150 mg q.d. Oral loading of flecainide,100 mg q.d.

Sponsors

Fujita Health University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Termination of atrial fibrillation within 120 min after treatment of propafenone or flecainide

Secondary

MeasureTime frame
Safety (blood pressure and proarrhythmia) Plasma drug concentration

Countries

Japan

Contacts

Public ContactEiichi Watanabe

Fujita Health University School of Medicine Department of Cardiology

enwatan@fujita-hu.ac.jp0562-93-2312

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026