Propafenone in the Treatment of Atrial Fibrillation

NCT ID: NCT03674658

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-11
• Study Completion Date: 2021-08-17

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 Patients present with the symptoms of arrhythmia after withdrawn from other prohibited anti-AF agents for at least 7 days and completed run-in period event recorded will be qualified for entering this study and will be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

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A drug

Rhynorm(A drug)

Group Type: EXPERIMENTAL

Propafenone

Intervention Type: DRUG

oral, TID

B drug

Rytmonorm (B drug)

Group Type: ACTIVE_COMPARATOR

Propafenone

Intervention Type: DRUG

oral, TID

Interventions

Propafenone

oral, TID

Intervention Type: DRUG

Other Intervention Names

A drug: Rhynorm; B drug: Rytmonorm

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TSH Biopharm Corporation Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

References

Chin CG, Hsieh YC, Lin WS, Lin YJ, Chiou CW, Lin TH, Huang CL, Hung Y, Lin YK, Chang SL, Yeh TC, Lee HC, Lai WT, Hsieh MH. An open-label randomized noninferior study of generic name and brand name of propafenone for rhythm control in patients with paroxysmal atrial fibrillation. J Chin Med Assoc. 2023 May 1;86(5):472-478. doi: 10.1097/JCMA.0000000000000903. Epub 2023 Feb 17.

Reference Type: DERIVED

PMID: 36800262 (View on PubMed)

Other Identifiers

TSHRH1801-P

Identifier Type: -

Identifier Source: org_study_id