MedTrace Logo

Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation

NCT01527279 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2015-05-22

No results posted yet for this study

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

Interventions

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.

DRUG

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.

Sponsors & Collaborators

  • National Institute of Cardiology, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Hanna Szwed, MD, PhD · National Institute of Cardiology, Warsaw, Poland

  • Aleksander Maciag, MD, PhD · National Institute of Cardiology, Warsaw, Poland

  • Michal M Farkowski, MD · National Institute of Cardiology, Warsaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-01-31
Completion
2015-03-31

Countries

  • Poland

Study Locations

More Related Trials

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 NCT01527279 on ClinicalTrials.gov