Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000308695
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
6/09/2005
Date last updated
26/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Perioperative ischaemic evaluation trial
Scientific title
The effect of perioperative metoprolol on cardiac morbidity and mortality in patients presenting for non-cardiac surgery
Secondary ID [1] 288012 0
Nil known
Universal Trial Number (UTN)
Trial acronym
POISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perioperative cardiac morbidity and mortality within 30 days of surgery 396 0
Condition category
Condition code
Surgery 468 468 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Metoprolol CR 200 mg daily for 30 days.
Intervention code [1] 304 0
Prevention
Comparator / control treatment
Placebo sugar tablet daily for 30 days
Control group
Placebo

Outcomes
Primary outcome [1] 529 0
Perioperative cardiac morbidity
Timepoint [1] 529 0
30 days after surgery
Primary outcome [2] 530 0
Perioperative cardiac mortality
Timepoint [2] 530 0
30 days after surgery
Secondary outcome [1] 1136 0
Safety outcomes
Timepoint [1] 1136 0
Within 30 days of surgery.

Eligibility
Key inclusion criteria
With or at risk of ischaemic heart disease. Having moderatie or high risk non-cardiac surgery.
Minimum age
45 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bradycardia or heart block, bronchospasm, recent CABG surgery, beta-blockers or verapamil.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central telephone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2003
Actual
31/01/2003
Date of last participant enrolment
Anticipated
Actual
28/07/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
10000
Accrual to date
Final
8351
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 524 0
Government body
Name [1] 524 0
CIHR
Country [1] 524 0
Canada
Funding source category [2] 525 0
Government body
Name [2] 525 0
NHMRC
Country [2] 525 0
Australia
Funding source category [3] 526 0
Commercial sector/Industry
Name [3] 526 0
AstraZeneca
Country [3] 526 0
Canada
Primary sponsor type
Commercial sector/Industry
Name
MediClin Pty Ltd
Address
1022 Malvern Rd, Armadale, Victoria, 3143
Country
Australia
Secondary sponsor category [1] 427 0
None
Name [1] 427 0
None
Address [1] 427 0
Country [1] 427 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1507 0
Royal Melbourne
Ethics committee address [1] 1507 0
Parkville, VIC, 3050
Ethics committee country [1] 1507 0
Australia
Date submitted for ethics approval [1] 1507 0
Approval date [1] 1507 0
Ethics approval number [1] 1507 0
2002.083
Ethics committee name [2] 1508 0
Alfred
Ethics committee address [2] 1508 0
Melbourne, VIC, 3004
Ethics committee country [2] 1508 0
Australia
Date submitted for ethics approval [2] 1508 0
Approval date [2] 1508 0
01/08/2002
Ethics approval number [2] 1508 0
Ethics committee name [3] 1509 0
Austin
Ethics committee address [3] 1509 0
Ethics committee country [3] 1509 0
Australia
Date submitted for ethics approval [3] 1509 0
Approval date [3] 1509 0
Ethics approval number [3] 1509 0
Ethics committee name [4] 1510 0
Western
Ethics committee address [4] 1510 0
Ethics committee country [4] 1510 0
Australia
Date submitted for ethics approval [4] 1510 0
Approval date [4] 1510 0
Ethics approval number [4] 1510 0
Ethics committee name [5] 1511 0
Box Hill
Ethics committee address [5] 1511 0
Ethics committee country [5] 1511 0
Australia
Date submitted for ethics approval [5] 1511 0
Approval date [5] 1511 0
Ethics approval number [5] 1511 0
Ethics committee name [6] 1512 0
Westmead
Ethics committee address [6] 1512 0
Ethics committee country [6] 1512 0
Australia
Date submitted for ethics approval [6] 1512 0
Approval date [6] 1512 0
Ethics approval number [6] 1512 0
Ethics committee name [7] 1513 0
Prince of Wales, Sydney
Ethics committee address [7] 1513 0
Ethics committee country [7] 1513 0
Australia
Date submitted for ethics approval [7] 1513 0
Approval date [7] 1513 0
Ethics approval number [7] 1513 0
Ethics committee name [8] 1514 0
Royal Prince Alfred
Ethics committee address [8] 1514 0
Ethics committee country [8] 1514 0
Australia
Date submitted for ethics approval [8] 1514 0
Approval date [8] 1514 0
Ethics approval number [8] 1514 0
Ethics committee name [9] 1515 0
Royal North Shore
Ethics committee address [9] 1515 0
Ethics committee country [9] 1515 0
Australia
Date submitted for ethics approval [9] 1515 0
Approval date [9] 1515 0
Ethics approval number [9] 1515 0
Ethics committee name [10] 1516 0
John Hunter
Ethics committee address [10] 1516 0
Ethics committee country [10] 1516 0
Australia
Date submitted for ethics approval [10] 1516 0
Approval date [10] 1516 0
Ethics approval number [10] 1516 0
Ethics committee name [11] 1517 0
Burnie
Ethics committee address [11] 1517 0
Ethics committee country [11] 1517 0
Australia
Date submitted for ethics approval [11] 1517 0
Approval date [11] 1517 0
Ethics approval number [11] 1517 0
Ethics committee name [12] 1518 0
Royal Perth
Ethics committee address [12] 1518 0
Ethics committee country [12] 1518 0
Australia
Date submitted for ethics approval [12] 1518 0
Approval date [12] 1518 0
Ethics approval number [12] 1518 0
Ethics committee name [13] 1519 0
Auckland City
Ethics committee address [13] 1519 0
Ethics committee country [13] 1519 0
New Zealand
Date submitted for ethics approval [13] 1519 0
Approval date [13] 1519 0
Ethics approval number [13] 1519 0
Ethics committee name [14] 1520 0
Middlemore
Ethics committee address [14] 1520 0
Ethics committee country [14] 1520 0
New Zealand
Date submitted for ethics approval [14] 1520 0
Approval date [14] 1520 0
Ethics approval number [14] 1520 0
Ethics committee name [15] 1521 0
Manukau
Ethics committee address [15] 1521 0
Ethics committee country [15] 1521 0
New Zealand
Date submitted for ethics approval [15] 1521 0
Approval date [15] 1521 0
Ethics approval number [15] 1521 0
Ethics committee name [16] 1522 0
Kuala Lumpur
Ethics committee address [16] 1522 0
Ethics committee country [16] 1522 0
Malaysia
Date submitted for ethics approval [16] 1522 0
Approval date [16] 1522 0
Ethics approval number [16] 1522 0
Ethics committee name [17] 1523 0
Penang
Ethics committee address [17] 1523 0
Ethics committee country [17] 1523 0
Malaysia
Date submitted for ethics approval [17] 1523 0
Approval date [17] 1523 0
Ethics approval number [17] 1523 0
Ethics committee name [18] 1524 0
University Hospital Singapore
Ethics committee address [18] 1524 0
Ethics committee country [18] 1524 0
Singapore
Date submitted for ethics approval [18] 1524 0
Approval date [18] 1524 0
Ethics approval number [18] 1524 0
Ethics committee name [19] 1525 0
Prince of Wales, Hong Kong
Ethics committee address [19] 1525 0
Ethics committee country [19] 1525 0
Hong Kong
Date submitted for ethics approval [19] 1525 0
Approval date [19] 1525 0
Ethics approval number [19] 1525 0
Ethics committee name [20] 1526 0
Geelong Hospital
Ethics committee address [20] 1526 0
Ethics committee country [20] 1526 0
Australia
Date submitted for ethics approval [20] 1526 0
Approval date [20] 1526 0
Ethics approval number [20] 1526 0
Ethics committee name [21] 1527 0
Warringal Hospital
Ethics committee address [21] 1527 0
Ethics committee country [21] 1527 0
Australia
Date submitted for ethics approval [21] 1527 0
Approval date [21] 1527 0
Ethics approval number [21] 1527 0

Summary
Brief summary
Patients with or at risk of ischaemic heart disease, who are having moderate or high risk non-cardiac surgery will be randomized to receive metoprolol CR or placebo for 30 days perioperatively. Outcomes include cardiac morbidity and mortality and safety endpoints.
Trial website
Trial related presentations / publications
The POISE Trial Group. Effects of extended-release metoprolol succinate in patients undergoing noncardiac surgery (the POISE trial): A randomised controlled trial. Lancet 2008; 371:1839-47
Public notes

Contacts
Principal investigator
Name 35664 0
Prof Kate Leslie
Address 35664 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Australia
Country 35664 0
Australia
Phone 35664 0
+61-3-93427540
Fax 35664 0
Email 35664 0
[email protected]
Contact person for public queries
Name 9493 0
Prof Associate Professor Kate Leslie
Address 9493 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Country 9493 0
Australia
Phone 9493 0
+61 3 93427000
Fax 9493 0
+61 3 93428623
Email 9493 0
[email protected]
Contact person for scientific queries
Name 421 0
Prof Associate Professor Kate Leslie
Address 421 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Country 421 0
Australia
Phone 421 0
+61 3 93427000
Fax 421 0
+61 3 93428623
Email 421 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.