Atrial FibrillationNCT03674658
Propafenone in the Treatment of Atrial Fibrillation
A study testing Propafenone in people with Atrial Fibrillation, run by TSH Biopharm Corporation Limited at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Propafenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jul 2019to 17 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Show all 29Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
About this study
Official title: An Open-Label Randomized Study of Propafenone in the Treatment of Atrial Fibrillation
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.
Read the 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
- Being tested
- Propafenone
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropafenoneDrug
Also called A drug: Rhynorm, B drug: Rytmonorm
oral, TID
| Study group | Role | What they receive |
|---|---|---|
| A drug | Experimental | Rhynorm(A drug) Receives: Drug: Propafenone |
| B drug | Active comparator | Rytmonorm (B drug) Receives: Drug: Propafenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start11 Jul 2019
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: Rhynorm (A drug) Group B: Rytmonorm (B drug)
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- TSH Biopharm Corporation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674658
- Sponsor's protocol ID
- TSHRH1801-P
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2018
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36800262
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Randomized Study of Propafenone in the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03674658
- Acronym / sponsor ID
- TSHRH1801-P
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- TSH Biopharm Corporation LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A: Rhynorm (A drug) Group B: Rytmonorm (B drug)
| Arm | Type | Receives |
|---|---|---|
| A drug | Experimental | Drug: PropafenoneRhynorm(A drug) |
| B drug | Active comparator | Drug: PropafenoneRytmonorm (B drug) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Patient may be receiving stable dose of propafenone since at least 4 weeks prior screening visit.
Key exclusion criteria (29 listed)
- Permanent or persistent AF
- Any of the following heart disease:
- Symptomatic Bradycardia (heart rate less than 50 beats per minute)
- Hemodynamic instability, defined as hypotension (SBP < 90 mm Hg)
- Hyperthyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropafenoneAlso: A drug: Rhynorm, B drug: Rytmonormoral, TID | Drug | A drug, B drug |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Derived from this study: PubMed 36800262Chin 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.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propafenone in people with Atrial Fibrillation, run by TSH Biopharm Corporation Limited at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with recurrent AF (time frame: 24 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03674658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.