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NCT05720572
Antazoline in Comparison to Propafenone in Pharmacological Cardioversion of Atrial Fibrillation.
Conditions: Atrial Fibrillation
Sex: All
Ages: 18 Years – 90 Years
Phase: PHASE4
Enrollment: 105
Sponsor: Centre of Postgraduate Medical Education
Location: Poland
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
Eligibility 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, PolandAge 18 to 90yearsAF lasting < 48 hoursStable cardio-pulmonary state on enrollmentIn case of unclear history of heart failure or suspicion of left ventricle damage echocardiographyis indicated prior to enrollmentExclusion Criteria:Lack of written informed consentAllergy to antazoline or propafenoneIntolerance of anatzoline or propafenoneAF related to significant valvular diseaseClinically significant heart failure or ejection fraction <50%Systolic blood pressure (BP) <100 mmHgHistory of significant bradyarrhythmia not treatedwith permanent pacemakerResting ventricular rate of < 80 bpm without pacemaker backupHeart rate > 140 bpmTachycardia >160'Advanced liver or kidney failureAcute coronary syndrome, coronary artery by-passgraft, stroke or transient ischemic attack within 30 days before enrollmentPreexcitation in ECG not treated by radiofrequency ablation of accessory pathwaySigns and symptoms of ischemia related to AFAn investigational drug used within 30 days before enrollmentAdvanced liver or kidney failureQT prolongation over 440 ms or QTc (Bazett's formula) over the population normPregnancy or breast feedingBackground therapy of any oral AADs.
Source: ClinicalTrials.gov (NCT05720572). StuddyBuddy aggregates publicly available trial information.