Back to resultsPropafenone in the Treatment of Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Propafenone
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Patients who are 20~80 years of age
- Recurrent AF patients
- Patients with paroxysmal atrial fibrillation
Patients diagnosed with one of the ECG monitoring within 12 months prior screening visit:
- 12-lead electrocardiogram
- ECG used to make a 30 second one of recording
- 24 hours ECG (Holter Monitor)
- Long term ECG (Event Monitor)
- Patient may be receiving stable dose of propafenone since at least 4 weeks prior screening visit.
- Agree to and are able to follow the study procedures
- Understand the nature of the study, and have signed informed consent forms
Exclusion Criteria:
- Permanent or persistent AF
Any of the following heart disease:
- New York Heart Association class III or IV angina pectoris or heart failure
- previous electrocardiographic evidence of second- or third-degree atrioventricular block;
- Sinus node disease, AV conduction disturbance or bundle branch block in the absence of an artificial pacemaker
- Hemodynamic moderate valvular heart disease (stenosis and/or incompetent; regurgitation)
- Brugada syndrome
- Left ventricular EF< 50%
- Acute myocardial infarction or unstable angina within the previous 12 months
- Cardiogenic shock (excluding arrhythrmia shock) within the previous 12 months
- Acute pericarditis or myocarditis within the previous 6 months
- Cardiac or thoracic surgery within the previous 6 months
- Symptomatic Bradycardia (heart rate less than 50 beats per minute)
- Hemodynamic instability, defined as hypotension (SBP < 90 mm Hg)
- Hyperthyroidism
- Bronchospastic disorders or severe obstructive pulmonary disease
- Correctable AF for other reasons
- Marked electrolyte imbalance
Patients with clinically significant abnormalities in the following laboratory parameters:
- AST or ALT ≥ 3X upper limit of normal (ULN)
- Total bilirubin ≥ 2X ULN
- Creatinine ≥ 2.5 mg/dL
- Hemoglobin < 10 g/dL
- Platelet < 100,000/uL
- Patients with known contraindication or history of allergy to Propafenone.
- Female patients who are pregnant or lactating.
- Female patients of child-bearing potentiality who do not agree to use an effective method of contraception during the study
- Patients currently participating in any drug related clinical trial within 30 days
- Patients with propagating factor (e.g. Alcohol Abuse induced AF)
Sites / Locations
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A drug
B drug
Arm Description
Rhynorm(A drug)
Rytmonorm (B drug)
Outcomes
Primary Outcome Measures
proportion of patients with recurrent AF
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03674658
First Posted
September 14, 2018
Last Updated
September 22, 2021
Sponsor
TSH Biopharm Corporation Limited
1. Study Identification
Unique Protocol Identification Number
NCT03674658
Brief Title
Propafenone in the Treatment of Atrial Fibrillation
Official Title
An Open-Label Randomized Study of Propafenone in the Treatment of Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 11, 2019 (Actual)
Primary Completion Date
August 17, 2021 (Actual)
Study Completion Date
August 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TSH Biopharm Corporation Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A: Rhynorm (A drug) Group B: Rytmonorm (B drug)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A drug
Arm Type
Experimental
Arm Description
Rhynorm(A drug)
Arm Title
B drug
Arm Type
Active Comparator
Arm Description
Rytmonorm (B drug)
Intervention Type
Drug
Intervention Name(s)
Propafenone
Other Intervention Name(s)
A drug: Rhynorm, B drug: Rytmonorm
Intervention Description
oral, TID
Primary Outcome Measure Information:
Title
proportion of patients with recurrent AF
Description
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
Time Frame
24 weeks treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are 20~80 years of age
Recurrent AF patients
Patients with paroxysmal atrial fibrillation
Patients diagnosed with one of the ECG monitoring within 12 months prior screening visit:
12-lead electrocardiogram
ECG used to make a 30 second one of recording
24 hours ECG (Holter Monitor)
Long term ECG (Event Monitor)
Patient may be receiving stable dose of propafenone since at least 4 weeks prior screening visit.
Agree to and are able to follow the study procedures
Understand the nature of the study, and have signed informed consent forms
Exclusion Criteria:
Permanent or persistent AF
Any of the following heart disease:
New York Heart Association class III or IV angina pectoris or heart failure
previous electrocardiographic evidence of second- or third-degree atrioventricular block;
Sinus node disease, AV conduction disturbance or bundle branch block in the absence of an artificial pacemaker
Hemodynamic moderate valvular heart disease (stenosis and/or incompetent; regurgitation)
Brugada syndrome
Left ventricular EF< 50%
Acute myocardial infarction or unstable angina within the previous 12 months
Cardiogenic shock (excluding arrhythrmia shock) within the previous 12 months
Acute pericarditis or myocarditis within the previous 6 months
Cardiac or thoracic surgery within the previous 6 months
Symptomatic Bradycardia (heart rate less than 50 beats per minute)
Hemodynamic instability, defined as hypotension (SBP < 90 mm Hg)
Hyperthyroidism
Bronchospastic disorders or severe obstructive pulmonary disease
Correctable AF for other reasons
Marked electrolyte imbalance
Patients with clinically significant abnormalities in the following laboratory parameters:
AST or ALT ≥ 3X upper limit of normal (ULN)
Total bilirubin ≥ 2X ULN
Creatinine ≥ 2.5 mg/dL
Hemoglobin < 10 g/dL
Platelet < 100,000/uL
Patients with known contraindication or history of allergy to Propafenone.
Female patients who are pregnant or lactating.
Female patients of child-bearing potentiality who do not agree to use an effective method of contraception during the study
Patients currently participating in any drug related clinical trial within 30 days
Patients with propagating factor (e.g. Alcohol Abuse induced AF)
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Propafenone in the Treatment of Atrial Fibrillation
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