Propafenone in the Treatment of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

An Open-Label Randomized Study of Propafenone in the Treatment of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03674658
• Other study ID #: TSHRH1801-P
• Status: Completed
• Phase: N/A
• Start date: July 11, 2019
• Est. completion date: August 17, 2021

Study information

• Verified date: September 2021
• Source: TSH Biopharm Corporation Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Patients present with the symptoms of arrhythmia after withdrawn from other prohibited anti-AF agents for at least 7 days and completed run-in period event recorded will be qualified for entering this study and will be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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 17, 2021
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients who are 20~80 years of age

2. Recurrent AF patients

3. Patients with paroxysmal atrial fibrillation

4. Patients diagnosed with one of the ECG monitoring within 12 months prior screening visit:

1. 12-lead electrocardiogram

2. ECG used to make a 30 second one of recording

3. 24 hours ECG (Holter Monitor)

4. Long term ECG (Event Monitor)

5. Patient may be receiving stable dose of propafenone since at least 4 weeks prior screening visit.

6. Agree to and are able to follow the study procedures

7. Understand the nature of the study, and have signed informed consent forms

Exclusion Criteria:

1. Permanent or persistent AF

2. Any of the following heart disease:

1. New York Heart Association class III or IV angina pectoris or heart failure

2. previous electrocardiographic evidence of second- or third-degree atrioventricular block;

3. Sinus node disease, AV conduction disturbance or bundle branch block in the absence of an artificial pacemaker

4. Hemodynamic moderate valvular heart disease (stenosis and/or incompetent; regurgitation)

5. Brugada syndrome

6. Left ventricular EF< 50%

7. Acute myocardial infarction or unstable angina within the previous 12 months

8. Cardiogenic shock (excluding arrhythrmia shock) within the previous 12 months

9. Acute pericarditis or myocarditis within the previous 6 months

10. Cardiac or thoracic surgery within the previous 6 months

3. Symptomatic Bradycardia (heart rate less than 50 beats per minute)

4. Hemodynamic instability, defined as hypotension (SBP < 90 mm Hg)

5. Hyperthyroidism

6. Bronchospastic disorders or severe obstructive pulmonary disease

7. Correctable AF for other reasons

8. Marked electrolyte imbalance

9. Patients with clinically significant abnormalities in the following laboratory parameters:

1. AST or ALT = 3X upper limit of normal (ULN)

2. Total bilirubin = 2X ULN

3. Creatinine = 2.5 mg/dL

4. Hemoglobin < 10 g/dL

5. Platelet < 100,000/uL

10. Patients with known contraindication or history of allergy to Propafenone.

11. Female patients who are pregnant or lactating.

12. Female patients of child-bearing potentiality who do not agree to use an effective method of contraception during the study

13. Patients currently participating in any drug related clinical trial within 30 days

14. Patients with propagating factor (e.g. Alcohol Abuse induced AF)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Propafenone
oral, TID

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
TSH Biopharm Corporation Limited

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 weeks treatment