Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

— AnPAF  

Official title:

Clinical Efficacy of Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation - a Single Centre, Randomized, Double-blind, Placebo-controlled Study (the AnPAF Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527279
• Other study ID #: Antazoline
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2012
• Last updated: May 21, 2015
• Start date: November 2012
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: The Central Register of Clinical Trials
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Drug:
• antazoline
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.
• 0.9% saline
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.

Locations

Country	Name	City	State
Poland	Institute of Cardiology, II Dept. of Coronary Heart Disease	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Farkowski MM, Maciag A, Dabrowski R, Pytkowski M, Kowalik I, Szwed H. Clinical efficacy of antazoline in rapid cardioversion of paroxysmal atrial fibrillation--a protocol of a single center, randomized, double-blind, placebo-controlled study (the AnPAF Study). Trials. 2012 Sep 11;13:162. doi: 10.1186/1745-6215-13-162. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion of AF to SN confirmed in standard 12-lead ECG during observation period after first iv bolus		1.5 hour	No
Secondary	Time to conversion of AF to SN	in minutes since first injection	1.5 hour	No
Secondary	Return of AF during observation period		1.5 hour	No
Secondary	Serious adverse event defined as every adverse event requiring hospitalization or prolonged observation		1.5 hour	Yes
Secondary	Arterial pressure < 90mmHg		1.5 hour	Yes
Secondary	Disturbances of atrio-ventricular conduction		1.5 hour	Yes
Secondary	Sustained supraventricular arrhythmia other than AF		1.5 hour	Yes
Secondary	New complex ventricular arrhythmia	Ventricular arrhythmia other than premature ventricular contraction	1.5 hour	Yes
Secondary	Hot flush		1.5 hour	Yes
Secondary	Drowsiness		1.5 hour	Yes
Secondary	Headache		1.5 hour	Yes
Secondary	Nausea/ vomiting		1.5 hour	Yes
Secondary	Chest pain		1.5 hours	Yes
Secondary	Tachycardia >180'		1.5 hours	Yes
Secondary	Prolongation of QTc in ms (Bazett's formula) in comparison to baseline		1.5 hours	Yes