Trial Outcomes & Findings for Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305 (NCT NCT00915356)
NCT ID: NCT00915356
Last Updated: 2012-02-01
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
228 participants
Primary outcome timeframe
At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).
Results posted on
2012-02-01
Participant Flow
The 1st patient was enrolled in the study on 25 May 2009, and the last patient completed the study on 4 December 2009. In total, 228 patients were enrolled (at 33 centres) and of the 171 patients randomised 170 patients completed the study. There was no discontinuation of the Investigational Product (IP) due to an Adverse Event (AE) in the 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).
Participant milestones
| Measure |
Placebo
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
AZD1305 Dose Group 1
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
26
|
45
|
45
|
12
|
|
Overall Study
COMPLETED
|
43
|
25
|
45
|
45
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
AZD1305 Dose Group 1
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305
Baseline characteristics by cohort
| Measure |
AZD1305 Dose Group 1
n=26 Participants
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=45 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=45 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=12 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
n=43 Participants
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
Age (years)
|
65 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
65 Years
STANDARD_DEVIATION 7 • n=7 Participants
|
64 Years
STANDARD_DEVIATION 10 • n=5 Participants
|
66 Years
STANDARD_DEVIATION 7 • n=4 Participants
|
66 Years
STANDARD_DEVIATION 9 • n=21 Participants
|
65 Years
STANDARD_DEVIATION 8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
62 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
109 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
AZD1305 Dose Group 1
n=25 Participants
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=45 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=45 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=12 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
n=42 Participants
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
|---|---|---|---|---|---|
|
Dose-response Relationship for QTcF Interval of AZD1305
|
461 ms
Interval 449.0 to 474.0
|
486 ms
Interval 476.0 to 495.0
|
490 ms
Interval 480.0 to 499.0
|
482 ms
Interval 464.0 to 500.0
|
440 ms
Interval 430.0 to 450.0
|
PRIMARY outcome
Timeframe: Within 90 minutes from start of infusionConversion of AF to SR with maintenance of SR maintained for at least 1 minute
Outcome measures
| Measure |
AZD1305 Dose Group 1
n=26 Participants
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=45 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=45 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=12 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
n=43 Participants
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
|---|---|---|---|---|---|
|
Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)
|
7.7 Percentage of patients converted to SR
Interval 0.9 to 25.1
|
17.8 Percentage of patients converted to SR
Interval 8.0 to 32.1
|
37.8 Percentage of patients converted to SR
Interval 23.8 to 53.5
|
50.0 Percentage of patients converted to SR
Interval 21.1 to 78.9
|
0.0 Percentage of patients converted to SR
Interval 0.0 to 8.2
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
AZD1305 Dose Group 1
n=26 Participants
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=45 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=45 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=12 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
n=43 Participants
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
|---|---|---|---|---|---|
|
Wide QRS Tachycardias
|
4 Participants
|
15 Participants
|
16 Participants
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SREarly 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.
Outcome measures
| Measure |
AZD1305 Dose Group 1
n=24 Participants
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=34 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=40 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=9 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
n=34 Participants
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
|---|---|---|---|---|---|
|
Heart Rhythm. Number of Participants With Early Relapse Into AF.
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During 24 hours following start of study drug infusionOutcome measures
| Measure |
AZD1305 Dose Group 1
n=26 Participants
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=45 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=45 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=12 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
n=43 Participants
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
|---|---|---|---|---|---|
|
Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion
|
23 Participants
|
34 Participants
|
36 Participants
|
10 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: During 13 to 18 days following study drug infusionNumber of patients in SR at day 13-18
Outcome measures
| Measure |
AZD1305 Dose Group 1
n=25 Participants
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=45 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=45 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=12 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
n=43 Participants
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
|---|---|---|---|---|---|
|
Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion.
|
14 Participants
|
23 Participants
|
25 Participants
|
7 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Since this study is no longer intended to be part of any marketing authorisation application, the analyses addressing this objective were not conducted.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 hours following start of study drug infusionPlasma concentration of AZD1305
Outcome measures
| Measure |
AZD1305 Dose Group 1
n=24 Participants
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=41 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=43 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=11 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
|---|---|---|---|---|---|
|
Maximal Observed Plasma Concentration of AZD1305
|
0.521 mol/L
Interval 0.157 to 0.991
|
1.28 mol/L
Interval 0.374 to 2.97
|
1.39 mol/L
Interval 0.017 to 3.17
|
1.69 mol/L
Interval 0.873 to 3.61
|
—
|
SECONDARY outcome
Timeframe: Conversion from AF to SR within 90 minutes from start of infusionOutcome measures
| Measure |
AZD1305 Dose Group 1
n=3 Participants
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=5 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=7 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=1 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
n=5 Participants
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
|---|---|---|---|---|---|
|
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
|
0 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Conversion from AF to SR within 90 minutes from start of infusionSubgroup analysis for patients with duration of current AF episode 8 days - 30 days. Number of patients converting from AF to SR.
Outcome measures
| Measure |
AZD1305 Dose Group 1
n=5 Participants
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=13 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=16 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=4 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
n=8 Participants
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
|---|---|---|---|---|---|
|
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.
|
0 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Conversion from AF to SR within 90 minutes from start of infusionSubgroup analysis for patients with duration of current AF episode 31 days - 3 months. Number of patients converting from AF to SR.
Outcome measures
| Measure |
AZD1305 Dose Group 1
n=18 Participants
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=27 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=22 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=7 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
n=30 Participants
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
|---|---|---|---|---|---|
|
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
|
2 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Six hours following start of study drug infusionPercentage, with 95% confidence interval, of patients with QTcF≤500 ms six hours following start of study drug infusion
Outcome measures
| Measure |
AZD1305 Dose Group 1
n=23 Participants
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=44 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=45 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=12 Participants
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
n=40 Participants
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
|---|---|---|---|---|---|
|
Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion
|
100.0 Percent of participants
Interval 85.2 to 100.0
|
95.5 Percent of participants
Interval 84.5 to 99.4
|
91.1 Percent of participants
Interval 78.8 to 97.5
|
100.0 Percent of participants
Interval 73.5 to 100.0
|
100.0 Percent of participants
Interval 91.2 to 100.0
|
Adverse Events
AZD1305 Dose Group 1
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
AZD1305 Dose Group 2
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
AZD1305 Dose Group 3
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
AZD1305 Dose Group 4
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD1305 Dose Group 1
n=26 participants at risk
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=45 participants at risk
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=45 participants at risk
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=12 participants at risk
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
n=43 participants at risk
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
1/26
|
2.2%
1/45
|
0.00%
0/45
|
0.00%
0/12
|
0.00%
0/43
|
|
Cardiac disorders
Sinus bradycardia
|
3.8%
1/26
|
0.00%
0/45
|
0.00%
0/45
|
0.00%
0/12
|
0.00%
0/43
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/26
|
2.2%
1/45
|
0.00%
0/45
|
0.00%
0/12
|
0.00%
0/43
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.00%
0/26
|
2.2%
1/45
|
0.00%
0/45
|
0.00%
0/12
|
0.00%
0/43
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/26
|
0.00%
0/45
|
2.2%
1/45
|
0.00%
0/12
|
0.00%
0/43
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/26
|
0.00%
0/45
|
2.2%
1/45
|
0.00%
0/12
|
0.00%
0/43
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
0/26
|
0.00%
0/45
|
2.2%
1/45
|
0.00%
0/12
|
0.00%
0/43
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26
|
0.00%
0/45
|
2.2%
1/45
|
0.00%
0/12
|
0.00%
0/43
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/26
|
0.00%
0/45
|
0.00%
0/45
|
8.3%
1/12
|
0.00%
0/43
|
|
Nervous system disorders
Presyncope
|
0.00%
0/26
|
0.00%
0/45
|
0.00%
0/45
|
8.3%
1/12
|
0.00%
0/43
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/26
|
0.00%
0/45
|
0.00%
0/45
|
0.00%
0/12
|
2.3%
1/43
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/26
|
0.00%
0/45
|
0.00%
0/45
|
0.00%
0/12
|
2.3%
1/43
|
Other adverse events
| Measure |
AZD1305 Dose Group 1
n=26 participants at risk
AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
|
AZD1305 Dose Group 2
n=45 participants at risk
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
|
AZD1305 Dose Group 3
n=45 participants at risk
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
|
AZD1305 Dose Group 4
n=12 participants at risk
AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
|
Placebo
n=43 participants at risk
Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/26
|
0.00%
0/45
|
0.00%
0/45
|
8.3%
1/12
|
0.00%
0/43
|
|
Cardiac disorders
Ventricular tachycardia
|
3.8%
1/26
|
0.00%
0/45
|
0.00%
0/45
|
8.3%
1/12
|
0.00%
0/43
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26
|
0.00%
0/45
|
2.2%
1/45
|
8.3%
1/12
|
2.3%
1/43
|
|
Cardiac disorders
Atrial fibrillation
|
11.5%
3/26
|
13.3%
6/45
|
11.1%
5/45
|
0.00%
0/12
|
9.3%
4/43
|
|
Cardiac disorders
Angina pectoris
|
7.7%
2/26
|
0.00%
0/45
|
0.00%
0/45
|
0.00%
0/12
|
0.00%
0/43
|
|
Nervous system disorders
Presyncope
|
0.00%
0/26
|
0.00%
0/45
|
0.00%
0/45
|
8.3%
1/12
|
0.00%
0/43
|
|
Nervous system disorders
Tension headache
|
0.00%
0/26
|
0.00%
0/45
|
0.00%
0/45
|
8.3%
1/12
|
0.00%
0/43
|
|
Infections and infestations
Gastritis fungal
|
0.00%
0/26
|
0.00%
0/45
|
0.00%
0/45
|
8.3%
1/12
|
0.00%
0/43
|
|
Vascular disorders
Hypertension
|
0.00%
0/26
|
6.7%
3/45
|
4.4%
2/45
|
0.00%
0/12
|
0.00%
0/43
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/26
|
0.00%
0/45
|
0.00%
0/45
|
8.3%
1/12
|
0.00%
0/43
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60