Overview

Clinical Efficacy and Safety of Antazoline in Comparison to Propafenone in Conversion of Paroxysmal Atrial Fibrillation to Sinus Rhythm - a Single Center, Randomized, Double-blinded Study (the AnPro Study).

Status:
Recruiting
Trial end date:
2026-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this randomized, double blind, non-inferiority clinical trial was to compare the clinical efficacy and safety of antazoline with propafenone in the rapid conversion of paroxysmal non-valvular atrial fibrillation to sinus rhythm in patients without heart failure
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre of Postgraduate Medical Education
Treatments:
Antazoline
Propafenone
Criteria
Inclusion Criteria:

- Written informed consent for participating in the study and written standard version
of informed consent for cardioversion accepted at the Department of Heart Disease,
Warsaw, Poland

- Age 18 to 90years

- AF lasting < 48 hours

- Stable cardio-pulmonary state on enrollment

- In case of unclear history of heart failure or suspicion of left ventricle damage
echocardiographyis indicated prior to enrollment

Exclusion Criteria:

- Lack of written informed consent

- Allergy to antazoline or propafenone

- Intolerance of anatzoline or propafenone

- AF related to significant valvular disease

- Clinically significant heart failure or ejection fraction <50%

- Systolic blood pressure (BP) <100 mmHg

- History of significant bradyarrhythmia not treatedwith permanent pacemaker

- Resting ventricular rate of < 80 bpm without pacemaker backup

- Heart rate > 140 bpm

- Tachycardia >160'

- Advanced liver or kidney failure

- Acute coronary syndrome, coronary artery by-passgraft, stroke or transient ischemic
attack within 30 days before enrollment

- Preexcitation in ECG not treated by radiofrequency ablation of accessory pathway

- Signs and symptoms of ischemia related to AF

- An investigational drug used within 30 days before enrollment

- Advanced liver or kidney failure

- QT prolongation over 440 ms or QTc (Bazett's formula) over the population norm

- Pregnancy or breast feeding

- Background therapy of any oral AADs.