Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305

Phase 2

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: AZD1305; Drug: Placebo

• Registration Number: NCT00915356
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-08
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2011-01-24
• Status Verified: 2012-01
• Results First Submitted QC: 2012-01-02
• Last Update Submitted: 2012-01-02
• Results First Posted: 2012-02-01
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD1305	AZD1305 iv infusion
2	Placebo	Placebo iv infusion

Primary Outcome Measures

Name	Time	Method
Dose-response Relationship for QTcF Interval of AZD1305	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
Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)	Within 90 minutes from start of infusion	Conversion of AF to SR with maintenance of SR maintained for at least 1 minute

Secondary Outcome Measures

Name	Time	Method
Wide QRS Tachycardias	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).
Heart Rhythm. Number of Participants With Early Relapse Into AF.	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.
Heart Rhythm. Number of Patients Remaining in SR up to 24 h 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.	During 13 to 18 days following study drug infusion	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.	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	Up to 24 hours following start of study drug infusion	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	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.	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 in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months	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.
Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion	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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden