Antazoline in Comparison to Propafenone in Pharmacological Cardioversion of Atrial Fibrillation.

NCT05720572 | Unknown Phase 4 DMC

• 1 other identifier: CMKP/85/PB/2019
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized, double blind, non-inferiority clinical trial was to compare the clinical efficacy and safety of antazoline with propafenone in the rapid conversion of paroxysmal non-valvular atrial fibrillation to sinus rhythm in patients without heart failure

Conditions

Atrial Fibrillation

Keywords

Antazoline; Antiarrhythmic drugs; Pharmacological cardioversion; Atrial fibrillation; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Conversion of atrial fibrillation (AF) to sinus rhythm (SR)

  Conversion of AF to SR confirmed in standard 12-lead ECG during the observation period

  3 hours

Secondary Outcomes (14)

• Time to conversion of atrial fibrillation to sinus rhythm

  3 hours

• Serious adverse event defined as every adverse event requiring hospitalization or prolonged observation

  3 hours

• Disturbances of atrioventricular conduction

  3 hours

• Hypotension < 90mmHg

  3 hours

• Pauses > 4s

  3 hours

Study Arms (2)

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 3 hours after the first 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

Propafenone

ACTIVE 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 3 hours after the first 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: Propafenone

Interventions

Antazoline DRUG

Participants assigned to the antazoline group will be administered antazoline in boluses in boluses of 100 mg diluted to 20 cm3 every 10 minutes up to a total dose of 300 mg diluted to 60 cm3 or conversion of AF to SR. Drug administration will also be stopped in case of an adverse event or conversion of AF to a different supraventricular arrhythmia. BP will be measured before every injection.

Antazoline

Propafenone DRUG

Patients assigned to the propafenone group were administered three 20-cm3 boluses every 10 minutes up to 60 cm3 or conversion of AF to SR. Each of the first two boluses included 70 mg propafenone (total dose 140 mg), and the third bolus contained only 20-cm3 0.9% NaCl. Drug administration will be stopped in case of an adverse event or conversion of AF to a different supraventricular arrhythmia. BP will be measured before every injection.

Propafenone

Eligibility Criteria

• Age: 18 Years - 90 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 at the Department of Heart Disease, Warsaw, Poland
• Age 18 to 90years
• AF lasting \< 48 hours
• Stable cardio-pulmonary state on enrollment
• In case of unclear history of heart failure or suspicion of left ventricle damage echocardiographyis indicated prior to enrollment

You may not qualify if:

• Lack of written informed consent
• Allergy to antazoline or propafenone
• Intolerance of anatzoline or propafenone
• AF related to significant valvular disease
• Clinically significant heart failure or ejection fraction \<50%
• Systolic blood pressure (BP) \<100 mmHg
• History of significant bradyarrhythmia not treatedwith permanent pacemaker
• Resting ventricular rate of \< 80 bpm without pacemaker backup
• Heart rate \> 140 bpm
• Tachycardia \>160'
• Advanced liver or kidney failure
• Acute coronary syndrome, coronary artery by-passgraft, 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

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

Postgraduate Medical School

Warsaw, 00-685, Poland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Antazoline; Propafenone

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; Propiophenones; Ketones; Organic Chemicals

Study Officials

• Jarosław JK Karwowski, PhD

  Centre of Postgraduate Medical Education

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jarosław JK Karwowski, PhD

CONTACT

+48502913169; karwowski.jarek@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After eligible patients provide informed consent, they are assigned a specific identifier. Neither the patient nor the researcher knows which group the subject will be assigned to. Patients are randomized according to the implemented random allocation sequence using numbered sealed envelopes, which are opened after inclusion of the patient for the study in a 1:1 ratio to treatment with antazoline or propafenone. After inclusion of the patient the study the nurse will open the numbered envelope and prepare three 10 cm3 syringes with study drugs according to randomization and pass them to the enrolling physician and nurse who will administer the drug. The patient, enrolling physician, nurse who administering the drug, and clinician reviewing the clinical outcomes will all be blinded to the treatment. The statistician, study nurse who prepares the syringes and clinician involved in safety control will be unblinded to the patient's assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study design This randomized, double-blind, placebo-controlled, non-inferiority clinical study is actually carried out at the Department of Heart Disease, Centre of Postgraduate Medical Education, Warsaw, Poland. The study will include 390 participants presenting with an episode of AF lasting less than 48 h. All participants must sign an informed consent form. The study protocol was approved by the local ethics committee and is in full compliance with the Declaration of Helsinki.

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: September 1, 2019
• Primary Completion: September 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

PL (1)