Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305

January 2, 2012 updated by: AstraZeneca

A Double-blind, Randomised, Placebo-controlled, Multicentre, Dose-escalating Study of AZD1305 Given Intravenously for Cardioversion of Atrial Fibrillation

This study is being carried out to see which dose of AZD1305 is safe and effective in cardioverting atrial fibrillation into normal heart rhythm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

228

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Praha 2, Czech Republic
        • Research Site
      • Znojmo, Czech Republic
        • Research Site
    • CZ
      • Brno, CZ, Czech Republic
        • Research Site
  • Denmark
      • Aalborg, Denmark
        • Research Site
      • Esbjerg, Denmark
        • Research Site
      • Svendborg, Denmark
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Cegled, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • Szekesfehervar, Hungary
        • Research Site
  • Netherlands
      • Breda, Netherlands
        • Research Site
      • Deventer, Netherlands
        • Research Site
      • Leeuwarden, Netherlands
        • Research Site
      • Sneek, Netherlands
        • Research Site
  • Norway
      • Hamar, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • RUD, Norway
        • Research Site
      • Tromso, Norway
        • Research Site
  • Poland
      • Bytom, Poland
        • Research Site
      • Lubin, Poland
        • Research Site
      • Plock, Poland
        • Research Site
      • Ruda Slaska, Poland
        • Research Site
      • Torun, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Slovakia
      • Martin, Slovakia
        • Research Site
      • Nitra, Slovakia
        • Research Site
      • Ruzomberok, Slovakia
        • Research Site
  • Sweden
      • Linkoping, Sweden
        • Research Site
      • Orebro, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical indication for cardioversion of Atrial Fibrillation, ie a correction of irregular heart rhythm to normal heart rhythm
  • Current episode of Atrial Fibrillation (ie irregular heart rhythm) lasting up to 3 months at randomisation
  • Adequate anticoagulation according to international guidelines (ACC/AHA/ESC, 2006) or national guidelines

Exclusion Criteria:

  • Potassium level below 3.8 mmol/L measured in serum or plasma
  • QTcF interval >440 ms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AZD1305 iv infusion
Drug: AZD1305
Intravenous (iv) single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes
Placebo Comparator: 2
Placebo iv infusion
Drug: Placebo
iv single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-response Relationship for QTcF Interval of AZD1305
Time Frame: At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).
QTcF-QT interval corrected for the RR interval (the time elapsing between two consecutive R waves in the electrocardiogram (ECG)) using the Fridericia formula.For each of 3 consecutive beats (5 consecutive beats if AF) a manual measurement, preferably in lead V2, of QTend intervals was done.The mean QT values of the 3 consecutive beats (5 consecutive beats if AF) were, together with RR intervals, date & time of the ECG, entered into the eCase Report Form (eCRF).The selected beats had to be marked with calipers and noted together with measured values and calculations on the print-out and signed
At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).
Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)
Time Frame: Within 90 minutes from start of infusion
Conversion of AF to SR with maintenance of SR maintained for at least 1 minute
Within 90 minutes from start of infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wide QRS Tachycardias
Time Frame: From start of study drug infusion until discharge from hospital on study day 2.
Number of patients with wide QRS tachycardias, determined as significant arrhythmias by an Adjudication Committee (AC). The AC analysed and classified the occurrence of significant arrhythmias (other than AF or AFl) and pauses based on the 12-lead Holter reports. All pauses (≥3 sec) and all wide QRS complex tachycardias (≥3 beats, QRS ≥120 ms, and ≥120 bpm).
From start of study drug infusion until discharge from hospital on study day 2.
Heart Rhythm. Number of Participants With Early Relapse Into AF.
Time Frame: Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR
Early relapse into AF within 5 minutes from obtaining the defined criterion for conversion to SR (i.e.1 minute in SR). Patients never converted are not included in the analysis.
Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR
Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion
Time Frame: During 24 hours following start of study drug infusion
During 24 hours following start of study drug infusion
Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion.
Time Frame: During 13 to 18 days following study drug infusion
Number of patients in SR at day 13-18
During 13 to 18 days following study drug infusion
Study the Relationship Between Systemic Exposure and Response, With Special Regards to Conversion of AF to SR and the Effect on the QTcF Interval.
Time Frame: Since this study is no longer intended to be part of any marketing authorisation application, the analyses addressing this objective were not conducted.
Since this study is no longer intended to be part of any marketing authorisation application, the analyses addressing this objective were not conducted.
Maximal Observed Plasma Concentration of AZD1305
Time Frame: Up to 24 hours following start of study drug infusion
Plasma concentration of AZD1305
Up to 24 hours following start of study drug infusion
Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 10 Hours to 7 Days
Time Frame: Conversion from AF to SR within 90 minutes from start of infusion
Conversion from AF to SR within 90 minutes from start of infusion
Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 8 Days - 30 Days.
Time Frame: Conversion from AF to SR within 90 minutes from start of infusion
Subgroup analysis for patients with duration of current AF episode 8 days - 30 days. Number of patients converting from AF to SR.
Conversion from AF to SR within 90 minutes from start of infusion
Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months
Time Frame: Conversion from AF to SR within 90 minutes from start of infusion
Subgroup analysis for patients with duration of current AF episode 31 days - 3 months. Number of patients converting from AF to SR.
Conversion from AF to SR within 90 minutes from start of infusion
Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion
Time Frame: Six hours following start of study drug infusion
Percentage, with 95% confidence interval, of patients with QTcF≤500 ms six hours following start of study drug infusion
Six hours following start of study drug infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AZD1305 Medical Science Director, AstraZeneca R&D, Mölndal, Sweden
  • Principal Investigator: Aladár Rónaszéki, Péterfy HospitalDepartment of Cardiology1076 Budapest, Péterfi Sándor str. 8-20HUNGARY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 8, 2009

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 2, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3191C00009
  • 2009-009862-15 (EudraCT No)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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