NCT03674658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

July 11, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

September 14, 2018

Last Update Submit

September 22, 2021

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

A drug

EXPERIMENTAL

Rhynorm(A drug)

Drug: Propafenone

B drug

ACTIVE COMPARATOR

Rytmonorm (B drug)

Drug: Propafenone

Interventions

PropafenoneDRUG

oral, TID

Also known as: A drug: Rhynorm, B drug: Rytmonorm
A drugB drug

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • lead electrocardiogram
  • ECG used to make a 30 second one of recording
  • 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

You may not qualify if:

  • 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)
  • 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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 36800262DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Propafenone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A: Rhynorm (A drug) Group B: Rytmonorm (B drug)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 17, 2018

Study Start

July 11, 2019

Primary Completion

August 17, 2021

Study Completion

August 17, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)