Propafenone in the Treatment of Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT03674658|
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Propafenone||Not Applicable|
This is a open label randomized, multi-center study conducted in Taiwan. The study aims to evaluate the effectiveness and safety of oral Rhynorm (A drug) and Rytmonorm (B drug) for the conversion of paroxysmal AF and is designed to evaluate the improvement in sinus rhythm restoration after the treatment with Rhynorm (A drug) and Rytmonorm (B drug) for 24 weeks.
This study comprised of three phases: a screening phase, a washout run-in qualifying phase lasting about 7 days, and a treatment phase of 24 weeks. A total of 60 evaluable subjects is planned to be enrolled. With an estimation of 20% dropout rate, 72 patients will be enrolled to reach 60 evaluable patients at the end of study. After screening for eligibility, the eligible subjects will be randomly assigned to either of the two gruop. The two-group are shown in the following table.
Group Treatment Drug Group A Rhynorm (A drug) Group B Rytmonorm (B drug) Patients with arrhythmia will be screened for eligibility after providing informed consent. Patients present with the symptoms of arrhythmia after withdrawn from other prohibited anti-AF agents for at least 7 days and completed run-in period event recorded will be qualified for entering this study and will be randomized to Rhynorm (A drug) treatment group or Rytmonorm (B drug) reference drud group in a 1:1 ratio.
The clinical evaluation will be recorded during the study period. Before treating with Rhynorm (A drug) and Rytmonorm (B drug), the physical examination and condition will be tracked and recorded for at least 7 days as the historical data.
During the treatment period, the subjects still had a routine OPD visit. Record symptom event and event recorder monitoring on OPD visit.
Safety assessments on all randomized subjects include adverse events, vital signs, and laboratory tests (hematology and biochemistry). Any adverse events, symptom events and concomitant medications/therapies will be recorded on the CRFs throughout the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Group A: Rhynorm (A drug) Group B: Rytmonorm (B drug)|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Randomized Study of Propafenone in the Treatment of Atrial Fibrillation|
|Actual Study Start Date :||July 11, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: A drug
Active Comparator: B drug
Rytmonorm (B drug)
- proportion of patients with recurrent AF [ Time Frame: 24 weeks treatment ]To compare the effect of Rhynorm (A drug) and Rytmonorm (B drug) over 24 weeks of treatment based on the proportion of patients with recurrent AF
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674658
|Contact: Jane Huang||+886-2-26558525 ext email@example.com|
|Kaohsiung Medical University Chung-Ho Memorial Hospital||Recruiting|