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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
228
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
Brno, CZ, Czechia
Dose-response Relationship for QTcF Interval of AZD1305
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
Time frame: 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)
Conversion of AF to SR with maintenance of SR maintained for at least 1 minute
Time frame: Within 90 minutes from start of infusion
Wide QRS Tachycardias
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).
Time frame: From start of study drug infusion until discharge from hospital on study day 2.
Heart Rhythm. Number of Participants With Early Relapse Into AF.
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.
Time frame: Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR
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Research Site
Prague, Czechia
Research Site
Znojmo, Czechia
Research Site
Aalborg, Denmark
Research Site
Esbjerg, Denmark
Research Site
Svendborg, Denmark
Research Site
Budapest, Hungary
Research Site
Cegléd, Hungary
Research Site
Debrecen, Hungary
Research Site
Kecskemét, Hungary
...and 21 more locations
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
Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion.
Number of patients in SR at day 13-18
Time frame: 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.
Maximal Observed Plasma Concentration of AZD1305
Plasma concentration of AZD1305
Time frame: 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 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 8 days - 30 days. Number of patients converting from AF to SR.
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 in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months
Subgroup analysis for patients with duration of current AF episode 31 days - 3 months. Number of patients converting from AF to SR.
Time frame: 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
Percentage, with 95% confidence interval, of patients with QTcF≤500 ms six hours following start of study drug infusion
Time frame: Six hours following start of study drug infusion