Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation
- Conditions
- Paroxysmal Atrial Fibrillation
- Interventions
- Drug: 0.9% saline
- Registration Number
- NCT01527279
- Lead Sponsor
- National Institute of Cardiology, Warsaw, Poland
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- Written informed consent for participating in the study and written standard version of informed consent for cardioversion accepted in Institute of Cardiology, Warsaw, Poland
- Age above 18 and good general condition
- Potassium level over 3.5 mmol/l
- Stable cardio-pulmonary state on enrollment
- In case of unclear history of heart failure or suspicion of impaired left ventricle function echocardiography is indicated prior to enrollment
- A long-term antiarrhythmic drug therapy is allowed
- Lack of written informed consent
- Antazoline allergy
- AF related to significant valvular disease
- Clinically significant heart failure or ejection fraction < 55%
- Diastolic blood pressure (BP) < 100mmHg
- History of significant bradyarrhythmia not treated with permanent pacemaker
- QT prolongation over 440ms or QTc (Bazett's formula) over population norm
- Tachycardia > 160'
- Advanced liver or kidney failure
- Acute coronary syndrome, coronary artery by-pass graft, 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
- Pregnancy or breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 0.9% saline Any patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. After drug administration the patient will be observed for 1.5 hour after the last dose with exit ECG and BP measure taken at the end of observation. Further treatment of the patient depends on clinical state and follows appropriate clinical guidelines. Antazoline antazoline Any patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. After drug administration the patient will be observed for 1.5 hour after the last dose with exit ECG and BP measure taken at the end of observation. Further treatment of the patient depends on clinical state and follows appropriate clinical guidelines.
- Primary Outcome Measures
Name Time Method Conversion of AF to SN confirmed in standard 12-lead ECG during observation period after first iv bolus 1.5 hour
- Secondary Outcome Measures
Name Time Method Hot flush 1.5 hour Time to conversion of AF to SN 1.5 hour in minutes since first injection
Arterial pressure < 90mmHg 1.5 hour Nausea/ vomiting 1.5 hour Chest pain 1.5 hours Tachycardia >180' 1.5 hours Sustained supraventricular arrhythmia other than AF 1.5 hour Drowsiness 1.5 hour Headache 1.5 hour Return of AF during observation period 1.5 hour Serious adverse event defined as every adverse event requiring hospitalization or prolonged observation 1.5 hour Disturbances of atrio-ventricular conduction 1.5 hour New complex ventricular arrhythmia 1.5 hour Ventricular arrhythmia other than premature ventricular contraction
Prolongation of QTc in ms (Bazett's formula) in comparison to baseline 1.5 hours
Trial Locations
- Locations (1)
Institute of Cardiology, II Dept. of Coronary Heart Disease
🇵🇱Warsaw, Poland