Propafenone in the Treatment of Atrial Fibrillation

Last updated: September 22, 2021
Sponsor: TSH Biopharm Corporation Limited
Overall Status: Completed

Phase

N/A

Condition

Cardiac Disease

Chest Pain

Dysrhythmia

Treatment

N/A

Clinical Study ID

NCT03674658
TSHRH1801-P
  • Ages 20-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 screeningvisit:
  5. 12-lead electrocardiogram
  6. ECG used to make a 30 second one of recording
  7. 24 hours ECG (Holter Monitor)
  8. Long term ECG (Event Monitor)
  9. Patient may be receiving stable dose of propafenone since at least 4 weeks priorscreening visit.
  10. Agree to and are able to follow the study procedures
  11. Understand the nature of the study, and have signed informed consent forms

Exclusion

Exclusion Criteria:

  1. Permanent or persistent AF
  2. Any of the following heart disease:
  3. New York Heart Association class III or IV angina pectoris or heart failure
  4. previous electrocardiographic evidence of second- or third-degreeatrioventricular block;
  5. Sinus node disease, AV conduction disturbance or bundle branch block in theabsence of an artificial pacemaker
  6. Hemodynamic moderate valvular heart disease (stenosis and/or incompetent;regurgitation)
  7. Brugada syndrome
  8. Left ventricular EF< 50%
  9. Acute myocardial infarction or unstable angina within the previous 12 months
  10. Cardiogenic shock (excluding arrhythrmia shock) within the previous 12 months
  11. Acute pericarditis or myocarditis within the previous 6 months
  12. Cardiac or thoracic surgery within the previous 6 months
  13. Symptomatic Bradycardia (heart rate less than 50 beats per minute)
  14. Hemodynamic instability, defined as hypotension (SBP < 90 mm Hg)
  15. Hyperthyroidism
  16. Bronchospastic disorders or severe obstructive pulmonary disease
  17. Correctable AF for other reasons
  18. Marked electrolyte imbalance
  19. Patients with clinically significant abnormalities in the following laboratoryparameters:
  20. AST or ALT ≥ 3X upper limit of normal (ULN)
  21. Total bilirubin ≥ 2X ULN
  22. Creatinine ≥ 2.5 mg/dL
  23. Hemoglobin < 10 g/dL
  24. Platelet < 100,000/uL
  25. Patients with known contraindication or history of allergy to Propafenone.
  26. Female patients who are pregnant or lactating.
  27. Female patients of child-bearing potentiality who do not agree to use an effectivemethod of contraception during the study
  28. Patients currently participating in any drug related clinical trial within 30 days
  29. Patients with propagating factor (e.g. Alcohol Abuse induced AF)

Study Design

Total Participants: 71
Study Start date:
July 11, 2019
Estimated Completion Date:
August 17, 2021

Study 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.

Connect with a study center

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

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