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Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00915356
First received: June 5, 2009
Last updated: January 2, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Atrial Fibrillation
Drug: AZD1305
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled, Multicentre, Dose-escalating Study of AZD1305 Given Intravenously for Cardioversion of Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: Yes ]
    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

  • Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR) [ Time Frame: Within 90 minutes from start of infusion ] [ Designated as safety issue: No ]
    Conversion of AF to SR with maintenance of SR maintained for at least 1 minute


Secondary Outcome Measures:
  • Wide QRS Tachycardias [ Time Frame: From start of study drug infusion until discharge from hospital on study day 2. ] [ Designated as safety issue: Yes ]
    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).

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
    Number of patients in SR at day 13-18

  • 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. ] [ Designated as safety issue: No ]
  • Maximal Observed Plasma Concentration of AZD1305 [ Time Frame: Up to 24 hours following start of study drug infusion ] [ Designated as safety issue: No ]
    Plasma concentration of AZD1305

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 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 ] [ Designated as safety issue: No ]
    Subgroup analysis for patients with duration of current AF episode 31 days - 3 months. Number of patients converting from AF to SR.

  • Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion [ Time Frame: Six hours following start of study drug infusion ] [ Designated as safety issue: Yes ]
    Percentage, with 95% confidence interval, of patients with QTcF≤500 ms six hours following start of study drug infusion


Enrollment: 228
Study Start Date: May 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915356

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00915356     History of Changes
Other Study ID Numbers: D3191C00009, 2009-009862-15 (EudraCT No)
Study First Received: June 5, 2009
Results First Received: January 24, 2011
Last Updated: January 2, 2012
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Slovakia: State Institute for Drug Control
Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
AZD1305
intravenous cardioversion of Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014