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Propafenone in the Treatment of Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674658
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
TSH Biopharm Corporation Limited

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Propafenone Not Applicable

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 Patients present with the symptoms of arrhythmia after withdrawn from other prohibited anti-AF agents for at least 7 days and completed run-in period event recorded will be qualified for entering this study and will be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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A: Rhynorm (A drug) Group B: Rytmonorm (B drug)
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A drug
Rhynorm(A drug)
Drug: Propafenone
oral, TID
Other Names:
  • A drug: Rhynorm
  • B drug: Rytmonorm

Active Comparator: B drug
Rytmonorm (B drug)
Drug: Propafenone
oral, TID
Other Names:
  • A drug: Rhynorm
  • B drug: Rytmonorm




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674658


Contacts
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Contact: Jane Huang +886-2-26558525 ext 5141 jane@tshbiopharm.com

Locations
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Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan
Sponsors and Collaborators
TSH Biopharm Corporation Limited
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Responsible Party: TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier: NCT03674658    
Other Study ID Numbers: TSHRH1801-P
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Propafenone
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action