Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation

NCT01527279 | Completed Phase 4 DMC

• 1 other identifier: Antazoline
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

atrial fibrillation; paroxysmal; cardioversion; antazoline

Outcome Measures

Primary Outcomes (1)

• Conversion of AF to SN confirmed in standard 12-lead ECG during observation period after first iv bolus

  1.5 hour

Secondary Outcomes (14)

• Time to conversion of AF to SN

  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

• Arterial pressure < 90mmHg

  1.5 hour

• Disturbances of atrio-ventricular conduction

  1.5 hour

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: 0.9% saline

Antazoline

EXPERIMENTAL

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.

Drug: antazoline

Interventions

antazoline DRUG

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.

Also known as: Phenazolinum

Antazoline

0.9% saline DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

Study Sites (1)

Institute of Cardiology, II Dept. of Coronary Heart Disease

Warsaw, 02-637, Poland

Location

Related Publications (2)

• 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.

  PMID: 22967497 BACKGROUND

• Maciag A, Farkowski MM, Chwyczko T, Beckowski M, Syska P, Kowalik I, Pytkowski M, Wozniak J, Dabrowski R, Szwed H. Efficacy and safety of antazoline in the rapid cardioversion of paroxysmal atrial fibrillation (the AnPAF Study). Europace. 2017 Oct 1;19(10):1637-1642. doi: 10.1093/europace/euw384.

  PMID: 28339554 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Antazoline; Saline Solution

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hanna Szwed, MD, PhD

  National Institute of Cardiology, Warsaw, Poland

  STUDY CHAIR

• Aleksander Maciag, MD, PhD

  National Institute of Cardiology, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

• Michal M Farkowski, MD

  National Institute of Cardiology, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 7, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

PL (1)