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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

Intravenous cardioversion of atrial fibrillation (AF) with 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

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

Research Site

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

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 AF to SR with maintenance of SR maintained for at least 1 minute

Age Continuous

Gender, Male/Female

Dose-response Relationship for QTcF Interval of AZD1305

Conversion of Atrial Fibrillation (AF) and maintenance of Sinus Rhytm (SR)

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).

Wide QRS Tachycardias

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 participants with early relapse into AF.

Heart rhythm. Number of patients remaining in SR up to 24 h following start of study drug infusion

Heart rhythm. Number of patients remaining in SR up to 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.

Maximal observed 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

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 8 days - 30 days.

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 in the subgroup of patients with duration of current AF episode 31 days - 3 months

Percentage, with 95% confidence interval, of  patients with  QTcF≤500 ms six hours following start of study drug infusion

Percentage of patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion

Overall Study

An enrolment visit (Visit 1) was done within 14 days before scheduled randomisation. Patients who fulfilled criteria and signed the informed consent form, could then be randomised at visit 2. The patients were to have ongoing Atrial Fibrillation with a clinical indication for cardioversion of Atrial Fibrillation (AF).

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

Intravenous cardioversion of atrial fibrillation (AF) with AZD1305

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Actual Enrollment

Study type

Age

Date

Study design

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Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=315&filename=CSR-D3191C00009.pdf

CSR-D3191C00009.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator