Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000639628
Ethics application status
Approved
Date submitted
11/10/2005
Date registered
13/10/2005
Date last updated
14/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of preoperative atenolol on morality and cardiovascular morbidity after non-cardiac surgery.
Scientific title
A prospective, double-blind randomised control study comparing the effect of atenolol versus placebo on mortality and cardiovascular morbidity in patients undergoing non-cardiac surgery.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing major non-cardiac surgery. 769 0
Condition category
Condition code
Cardiovascular 845 845 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double-blind, randomised control trial comparing atenolol or placebo given preoperatively and for 7 days postoperatively. Patients are telephoned at 3 months, 6 months, 12 months and 2 years postoperatively to follow up on mortality and cardiovascular morbidity.
Intervention code [1] 710 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1083 0
Patient mortality
Timepoint [1] 1083 0
Measured at 3 months, 6 months, 12 months and 2 years post op.
Primary outcome [2] 1084 0
Cardiovascular morbidity
Timepoint [2] 1084 0
Measured at 3 months, 6 months, 12 months and 2 years post op.
Secondary outcome [1] 2018 0
No secondary outcome.
Timepoint [1] 2018 0
24 hours post op

Eligibility
Key inclusion criteria
Any patient undergoing major surgery under general anaesthesia who has at least 2 of the following risk factors for coronary artery disease: diabetes, hypertension, current smoker, cholesterol > 6.2mmol/L.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known coronary artery disease, long term beta-blocker use, poorly compensated CCF, 3rd degree heart block, inducible bronchospasm (unstable asthma).

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)
Sealed envelopes opened at the time of randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computor software PC-Plan used to generate random allocation
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
1/12/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 931 0
Self funded/Unfunded
Name [1] 931 0
Country [1] 931 0
Primary sponsor type
Hospital
Name
Department of Anaesthesia, St Vincent's Hospital, Melbourne
Address
Fitzroy
Country
Australia
Secondary sponsor category [1] 790 0
None
Name [1] 790 0
No secondary sponsor
Address [1] 790 0
Country [1] 790 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35189 0
Address 35189 0
Country 35189 0
Phone 35189 0
Fax 35189 0
Email 35189 0
Contact person for public queries
Name 9899 0
Simone Said
Address 9899 0
Department of Anaesthesia
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 9899 0
Australia
Phone 9899 0
+61 3 92884245
Fax 9899 0
Email 9899 0
simone.SAID@svhm.org.au
Contact person for scientific queries
Name 827 0
Dr Roman Kluger
Address 827 0
Department of Anaesthesia
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 827 0
Australia
Phone 827 0
+61 3 92884245
Fax 827 0
Email 827 0
roman.KLUGER@svhm.org.au

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.