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

NCT05720572 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-02-14

No results posted yet for this study

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

Interventions

DRUG

Antazoline

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.

DRUG

Propafenone

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.

Sponsors & Collaborators

  • Centre of Postgraduate Medical Education

    lead OTHER

Principal Investigators

  • Jarosław JK Karwowski, PhD · Centre of Postgraduate Medical Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2025-09-01
Completion
2026-01-01

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05720572 on ClinicalTrials.gov