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Completed

NCT Number: NCT00915356

Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Brno, CZ, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1305

Drug

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

Drug

iv single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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).

  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.

  3. 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

  4. 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

  5. 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.

  6. Maximal Observed Plasma Concentration of AZD1305

    Time frame: Up to 24 hours following start of study drug infusion

    Plasma concentration of AZD1305

  7. 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

  8. 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.

  9. 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.

  10. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 8, 2009
Registry last updated
Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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