The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial was to assess clinical efficacy of antazoline in rapid conversion of atrial fibrillation during observation sinus rhythm.
Antazoline is a first generation antihistaminic agent with chinidin-like properties. When administered intravenously, antazoline exerts a strong antiarrhythmic effect on supraventricular arrhythmia especially on atrial fibrillation (AF) facilitating rapid conversion to sinus rhythm. Despite relative lack of published data antazoline is marketed in Poland and widely used in cardiology wards and emergency rooms due to its efficacy, safety and rapid onset of action within minutes of administration. To show superiority of antazoline over placebo a sample size of 80 patients was calculated based on following assumptions: two-tailed test, a type I error of 0.01, a power of 90%, efficacy of placebo 5%, efficacy of antazoline 50% and 20% drop-out rate to fulfill the criteria of intention-to-treat analysis. Due to presumed lack of statistical power the secondary end points and safety endpoints will be considered exploratory.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
74
Patients assigned to antazoline group will be administered antazoline in boluses of 50mg diluted to 10cm3 every 5 minutes up to cumulative dose of 250mg or conversion of AF to SN. Drug administration will also be stopped in case of serious adverse event or conversion of AF to different supraventricular arrhythmia. BP will be measured before every injection.
Patients assigned to control group will be administered 0.9% saline in boluses of 10cm3 every 5 minutes up to cumulative volume of 50cm3, conversion of AF to SN or in case of serious adverse event or conversion of AF to different supraventricular arrhythmia. BP will be measured before every injection.
Institute of Cardiology, II Dept. of Coronary Heart Disease
Warsaw, Poland
Conversion of AF to SN confirmed in standard 12-lead ECG during observation period after first iv bolus
Time frame: 1.5 hour
Time to conversion of AF to SN
in minutes since first injection
Time frame: 1.5 hour
Return of AF during observation period
Time frame: 1.5 hour
Serious adverse event defined as every adverse event requiring hospitalization or prolonged observation
Time frame: 1.5 hour
Arterial pressure < 90mmHg
Time frame: 1.5 hour
Disturbances of atrio-ventricular conduction
Time frame: 1.5 hour
Sustained supraventricular arrhythmia other than AF
Time frame: 1.5 hour
New complex ventricular arrhythmia
Ventricular arrhythmia other than premature ventricular contraction
Time frame: 1.5 hour
Hot flush
Time frame: 1.5 hour
Drowsiness
Time frame: 1.5 hour
Headache
Time frame: 1.5 hour
Nausea/ vomiting
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Time frame: 1.5 hour
Chest pain
Time frame: 1.5 hours
Tachycardia >180'
Time frame: 1.5 hours
Prolongation of QTc in ms (Bazett's formula) in comparison to baseline
Time frame: 1.5 hours