Trial Outcomes & Findings for A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients (NCT NCT01396226)

NCT ID: NCT01396226

Last Updated: 2012-11-27

Results Overview

Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline to last assessment during IP infusion
• Results posted on: 2012-11-27

Participant Flow

The study had enrolled 20 patients. A total of 18 patients were randomised of which 12 patients received AZD2927. All patients who received treatment completed the study.

Participant milestones

Measure	AZD2927 AZD2927 solution for infusion	PLACEBO Placebo solution for infusion
Overall Study STARTED	12	6
Overall Study Patients Who Received Treatment	12	6
Overall Study Patients Who Completed Treatment	12	6
Overall Study COMPLETED	12	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients

Baseline characteristics by cohort

Measure	AZD2927 n=12 Participants AZD2927 solution for infusion	PLACEBO n=6 Participants Placebo solution for infusion	Total n=18 Participants Total of all reporting groups
Age Continuous	57.9 Years STANDARD_DEVIATION 7.7 • n=93 Participants	63.8 Years STANDARD_DEVIATION 8.3 • n=4 Participants	59.9 Years STANDARD_DEVIATION 8.2 • n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	5 Participants n=4 Participants	16 Participants n=27 Participants
Race/Ethnicity, Customized White	12 Participants n=93 Participants	6 Participants n=4 Participants	18 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to last assessment during IP infusion

Population: Full A analysis Set (FAS)

Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion

Outcome measures

Measure	Arm 1 - AZD2927 n=12 Participants AZD2927 solution for intravenous (i.v.) infusion	Arm 2 - PLACEBO n=6 Participants Placebo solution for intravenous (i.v.) infusion
Left Atrial Effective Refractory Period 1st Assessment	2.5 msec Standard Deviation 8.9	5 msec Standard Deviation 23
Left Atrial Effective Refractory Period 2nd Assessment	2.5 msec Standard Deviation 9.7	10.8 msec Standard Deviation 34.4

PRIMARY outcome

Timeframe: Baseline to last assessment during IP infusion

Population: Per Protocol (PP)

Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion

Outcome measures

Measure	Arm 1 - AZD2927 n=11 Participants AZD2927 solution for intravenous (i.v.) infusion	Arm 2 - PLACEBO n=6 Participants Placebo solution for intravenous (i.v.) infusion
Left Atrial Effective Refractory Period 1st Assessment	2.7 msec Standard Deviation 9.3	5 msec Standard Deviation 23
Left Atrial Effective Refractory Period 2nd Assessment	2.7 msec Standard Deviation 10.1	10.8 msec Standard Deviation 34.4

SECONDARY outcome

Timeframe: Baseline to last assessment during IP infusion

Population: FAS

Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion

Outcome measures

Measure	Arm 1 - AZD2927 n=12 Participants AZD2927 solution for intravenous (i.v.) infusion	Arm 2 - PLACEBO n=6 Participants Placebo solution for intravenous (i.v.) infusion
Ventricular Effective Refractory Period	-0.8 msec Standard Deviation 9	1.7 msec Standard Deviation 7.5

SECONDARY outcome

Timeframe: Baseline to last assessment during IP infusion

Population: FAS

Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements

Outcome measures

Measure	Arm 1 - AZD2927 n=12 Participants AZD2927 solution for intravenous (i.v.) infusion	Arm 2 - PLACEBO n=6 Participants Placebo solution for intravenous (i.v.) infusion
Paced QT Interval	-0.9 msec Standard Deviation 8.7	6.3 msec Standard Deviation 8.4

SECONDARY outcome

Timeframe: Baseline to last assessment during IP infusion

Population: FAS

Change from observation before IP infusion to during 1st and 2nd LAERP Mean

Outcome measures

Measure	Arm 1 - AZD2927 n=8 Participants AZD2927 solution for intravenous (i.v.) infusion	Arm 2 - PLACEBO n=6 Participants Placebo solution for intravenous (i.v.) infusion
Atrio-ventricular Effective Refractory Period During IP 1st LAERP Mean	-16.9 msec Standard Deviation 18.1	1.7 msec Standard Deviation 18.1
Atrio-ventricular Effective Refractory Period During IP 2nd LAERP Mean	-19.4 msec Standard Deviation 17.6	3.2 msec Standard Deviation 16.5

SECONDARY outcome

Timeframe: Baseline to last assessment during IP infusion

Population: FAS

Reflects intra-atrial conduction and is defined as the interval from the onset of the P wave in the surface ECG to the onset of atrial activation (A) in the His bundle electrogram. Change from observation before IP infusion to 30 min after IP start

Outcome measures

Measure	Arm 1 - AZD2927 n=12 Participants AZD2927 solution for intravenous (i.v.) infusion	Arm 2 - PLACEBO n=6 Participants Placebo solution for intravenous (i.v.) infusion
PA Interval	1.7 msec Standard Deviation 12	9.3 msec Standard Deviation 15.4

SECONDARY outcome

Timeframe: Baseline to last assessment during IP infusion

Population: FAS

Change from observation before IP infusion to 30 mins after IP start. AH interval- the conduction time from the low right atrium at the inter-atrial septum through the AV node to the His bundle, ie, intra-nodal conduction time.

Outcome measures

Measure	Arm 1 - AZD2927 n=12 Participants AZD2927 solution for intravenous (i.v.) infusion	Arm 2 - PLACEBO n=6 Participants Placebo solution for intravenous (i.v.) infusion
AH Interval	0 msec Standard Deviation 14.2	-2.2 msec Standard Deviation 12.1

SECONDARY outcome

Timeframe: Baseline to last assessment during IP infusion

Population: FAS

Change from observation before IP infusion to 30 mins after IP start. HV interval - represents conduction time from the proximal His bundle to the ventricular myocardium, ie, infra-nodal conduction time.

Outcome measures

Measure	Arm 1 - AZD2927 n=12 Participants AZD2927 solution for intravenous (i.v.) infusion	Arm 2 - PLACEBO n=6 Participants Placebo solution for intravenous (i.v.) infusion
HV Interval	-3.5 msec Standard Deviation 8.9	3.5 msec Standard Deviation 4.9

SECONDARY outcome

Timeframe: Baseline to last assessment during IP infusion

Population: FAS

Interval from the onset of the P-wave to the start of the QRS complex. Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion

Outcome measures

Measure	Arm 1 - AZD2927 n=12 Participants AZD2927 solution for intravenous (i.v.) infusion	Arm 2 - PLACEBO n=6 Participants Placebo solution for intravenous (i.v.) infusion
PR Interval 06:00-08:00	-5.1 msec Standard Deviation 17.0	19.3 msec Standard Deviation 17.9
PR Interval 20:00-24:00	-8.0 msec Standard Deviation 18.6	4.3 msec Standard Deviation 21.4

SECONDARY outcome

Timeframe: Baseline to last assessment during IP infusion

Population: FAS

Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion

Outcome measures

Measure	Arm 1 - AZD2927 n=12 Participants AZD2927 solution for intravenous (i.v.) infusion	Arm 2 - PLACEBO n=6 Participants Placebo solution for intravenous (i.v.) infusion
QRS Duration 06:00-08:00	-1.2 msec Standard Deviation 6.1	-0.3 msec Standard Deviation 8.5
QRS Duration 20:00-24:00	-2.5 msec Standard Deviation 9.6	-2.5 msec Standard Deviation 7.3

SECONDARY outcome

Timeframe: Baseline to last assessment during IP infusion

Population: FAS

Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion

Outcome measures

Measure	Arm 1 - AZD2927 n=12 Participants AZD2927 solution for intravenous (i.v.) infusion	Arm 2 - PLACEBO n=6 Participants Placebo solution for intravenous (i.v.) infusion
RR Interval 06:00-08:00	21.3 msec Standard Deviation 170.4	57.2 msec Standard Deviation 74.2
RR Interval 20:00-24:00	-11.5 msec Standard Deviation 202	-8.3 msec Standard Deviation 139.9

SECONDARY outcome

Timeframe: Baseline to last assessment during IP infusion

Population: PP

Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion

Outcome measures

Measure	Arm 1 - AZD2927 n=11 Participants AZD2927 solution for intravenous (i.v.) infusion	Arm 2 - PLACEBO n=6 Participants Placebo solution for intravenous (i.v.) infusion
Ventricular Effective Refractory Period	-0.9 msec Standard Deviation 9.4	1.7 msec Standard Deviation 7.5

SECONDARY outcome

Timeframe: Baseline to last assessment during IP infusion

Population: PP

Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements

Outcome measures

Measure	Arm 1 - AZD2927 n=11 Participants AZD2927 solution for intravenous (i.v.) infusion	Arm 2 - PLACEBO n=6 Participants Placebo solution for intravenous (i.v.) infusion
Paced QT Interval	-1.0 msec Standard Deviation 9.1	6.3 msec Standard Deviation 8.4

Adverse Events

AZD2927

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

PLACEBO

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AZD2927 n=12 participants at risk AZD2927 solution for infusion	PLACEBO n=6 participants at risk Placebo solution for infusion
Cardiac disorders ATRIAL FIBRILLATION	8.3% 1/12	16.7% 1/6
Cardiac disorders Atrial Flutter	0.00% 0/12	16.7% 1/6
Injury, poisoning and procedural complications MEDICAL DEVICE COMPLICATION	8.3% 1/12	0.00% 0/6

Additional Information

Gerard Lynch

AstraZeneca

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60