Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000031763
Ethics application status
Approved
Date submitted
2/01/2013
Date registered
11/01/2013
Date last updated
11/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Statin Therapy in Ischemia-Reperfusion Injury during coronary artery bypass grafting.
Scientific title
Statin therapy in Ischemia-Reperfusion Injury: A randomised trial to evaluate the effect of high dose rosuvastatin on myocardial infarct size post coronary artery bypass grafting (CABG).
Secondary ID [1] 281715 0
Nil
Universal Trial Number (UTN)
U1111-1138-1724
Trial acronym
STIR (CABG)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post CABG ischemia reperfusion injury (IRI) 288014 0
Condition category
Condition code
Cardiovascular 288388 288388 0 0
Coronary heart disease
Surgery 288440 288440 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rosuvastatin 40mgs orally at 36 hours and 12 hours pre CABG and then rosuvastatin 40 mgs daily for 7 days post CABG.
Intervention code [1] 286253 0
Treatment: Drugs
Comparator / control treatment
The control group will receive standard care as per normal clinical practice for the treatment of CABG patients which will include being prescribed a medication from the statin group but not at as large a dose as this would have precluded them from being randomised into the study.
Control group
Active

Outcomes
Primary outcome [1] 288563 0
Myocardial Infarct (MI) size as assessed by CMR late gadolinium-enhancement
Timepoint [1] 288563 0
At Baseline (up to 30 days before CABG) and then 5-10 days post CABG surgery
Secondary outcome [1] 300467 0
Biochemical markers of myocardial injury will be assessed by calculating the total area under the curve of the cardiac enzyme levels (CK, CKMB and Hs Troponin T) taken over an 120 hour period.
Timepoint [1] 300467 0
Baseline(0 Hours) pre CABG, 6, 12, 24, 48, 72 and 120 hours

Eligibility
Key inclusion criteria
Adult patients who are scheduled to undergo elective on-pump CABG with or without aortic valve replacement.
For patients on statins pre-CABG, statin dose must be unchanged for 30 days pre-CABG.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Standard CMR contra-indications
Known intolerance to statins
Renal (eGFR <45mls/min) and hepatic impairment
Emergency CABG
Mitral or tricuspid valve repair or replacement
Off-pump CABG
Patients who are Filipino, Chinese, Japanese, Korean or Vietnamese
Patients on cyclosporine, gemfibrozil or fisidic acid
Patients who are already on rosuvastatin or atorvastatin 80 mgs pre-CABG
Re-do surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 348 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 349 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 6143 0
5042 - Bedford Park
Recruitment postcode(s) [2] 6144 0
5001 - Adelaide

Funding & Sponsors
Funding source category [1] 286507 0
Other
Name [1] 286507 0
South Australian Health and Medical Research Institute
Country [1] 286507 0
Australia
Primary sponsor type
Other
Name
South Australian Health and Medical Research Institute
Address
Level 9, 121 King William Street, PO Box 11060
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 285295 0
None
Name [1] 285295 0
Address [1] 285295 0
Country [1] 285295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288581 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 288581 0
Ethics committee country [1] 288581 0
Australia
Date submitted for ethics approval [1] 288581 0
Approval date [1] 288581 0
19/12/2012
Ethics approval number [1] 288581 0
378.12

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

Contacts
Principal investigator
Name 36782 0
Prof Joseph Selvanayagam
Address 36782 0
Department of Cardiovascular Medicine
Flinders Medical Centre
Flinders Drive
BEDFORD PARK SA 5042
Country 36782 0
Australia
Phone 36782 0
+61 8 8404 2195
Fax 36782 0
Email 36782 0
joseph.selvanayagam@flinders.edu.au
Contact person for public queries
Name 36783 0
Christine Edwards
Address 36783 0
SAHMRI
Mark Oliphant Building
Box 15
Laffer Drive, Science Park
Bedford Park SA 5042
Country 36783 0
Australia
Phone 36783 0
+61 8 8201 5656
Fax 36783 0
+61 8 8201 7701
Email 36783 0
christine.edwards@sahmri.com
Contact person for scientific queries
Name 36784 0
Joseph Selvanayagam
Address 36784 0
Department of Cardiovascular Medicine
Flinders Medical Centre
Flinders Drive
BEDFORD PARK SA 5042
Country 36784 0
Australia
Phone 36784 0
+61 8 8404 2195
Fax 36784 0
Email 36784 0
joseph.selvanayagam@flinders.edu.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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 363431-(Uploaded-18-08-2020-11-22-48)-Basic results summary.docx
Plain language summaryNo Open heart surgery is associated with low morbidit... [More Details]

Documents added automatically
No additional documents have been identified.