Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation (AnPAF)

National Institute of Cardiology, Warsaw, Poland

Status and phase: Completed; Phase 4

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Drug: 0.9% saline; Drug: antazoline

Study type: Interventional

Funder types: Other

Identifiers

NCT01527279

Antazoline

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

74 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: 0.9% saline

Antazoline

Experimental group

Description:

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.

Treatment:

Drug: antazoline