search
Back to results

Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation (AnPAF)

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
antazoline
0.9% saline
Sponsored by
National Institute of Cardiology, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring atrial fibrillation, paroxysmal, cardioversion, antazoline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute of Cardiology, II Dept. of Coronary Heart Disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Antazoline

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to conversion of AF to SN
in minutes since first injection
Return of AF during observation period
Serious adverse event defined as every adverse event requiring hospitalization or prolonged observation
Arterial pressure < 90mmHg
Disturbances of atrio-ventricular conduction
Sustained supraventricular arrhythmia other than AF
New complex ventricular arrhythmia
Ventricular arrhythmia other than premature ventricular contraction
Hot flush
Drowsiness
Headache
Nausea/ vomiting
Chest pain
Tachycardia >180'
Prolongation of QTc in ms (Bazett's formula) in comparison to baseline

Full Information

First Posted
February 2, 2012
Last Updated
May 21, 2015
Sponsor
National Institute of Cardiology, Warsaw, Poland
search

1. Study Identification

Unique Protocol Identification Number
NCT01527279
Brief Title
Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
atrial fibrillation, paroxysmal, cardioversion, antazoline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Antazoline
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
antazoline
Other Intervention Name(s)
Phenazolinum
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Conversion of AF to SN confirmed in standard 12-lead ECG during observation period after first iv bolus
Time Frame
1.5 hour
Secondary Outcome Measure Information:
Title
Time to conversion of AF to SN
Description
in minutes since first injection
Time Frame
1.5 hour
Title
Return of AF during observation period
Time Frame
1.5 hour
Title
Serious adverse event defined as every adverse event requiring hospitalization or prolonged observation
Time Frame
1.5 hour
Title
Arterial pressure < 90mmHg
Time Frame
1.5 hour
Title
Disturbances of atrio-ventricular conduction
Time Frame
1.5 hour
Title
Sustained supraventricular arrhythmia other than AF
Time Frame
1.5 hour
Title
New complex ventricular arrhythmia
Description
Ventricular arrhythmia other than premature ventricular contraction
Time Frame
1.5 hour
Title
Hot flush
Time Frame
1.5 hour
Title
Drowsiness
Time Frame
1.5 hour
Title
Headache
Time Frame
1.5 hour
Title
Nausea/ vomiting
Time Frame
1.5 hour
Title
Chest pain
Time Frame
1.5 hours
Title
Tachycardia >180'
Time Frame
1.5 hours
Title
Prolongation of QTc in ms (Bazett's formula) in comparison to baseline
Time Frame
1.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Szwed, MD, PhD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aleksander Maciag, MD, PhD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michal M Farkowski, MD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Cardiology, II Dept. of Coronary Heart Disease
City
Warsaw
ZIP/Postal Code
02-637
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
22967497
Citation
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.
Results Reference
background
PubMed Identifier
28339554
Citation
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.
Results Reference
derived

Learn more about this trial

Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation

We'll reach out to this number within 24 hrs