Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000032752
Ethics application status
Approved
Date submitted
3/01/2013
Date registered
11/01/2013
Date last updated
25/07/2019
Date data sharing statement initially provided
25/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Statin Therapy in Ischemia-Reperfusion Injury sustained during a heart attack
Scientific title
Statin Therapy in Ischemia-Reperfusion Injury: A randomised trial to evaluate the effect of high dose rosuvastatin on myocardial infarct size post ST elevation myocardial infarction (STEMI).
Secondary ID [1] 281724 0
None
Universal Trial Number (UTN)
U1111-1138-1887
Trial acronym
STIR (STEMI)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute ST Elevation Myocardial Infarction 288022 0
Condition category
Condition code
Cardiovascular 288399 288399 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rosuvastatin 40 mgs orally on randomisation and daily for 5 days post angioplasty. Angioplasty is performed as soon as possible post randomisation.
Intervention code [1] 286262 0
Treatment: Drugs
Comparator / control treatment
Placebo (Microcrystalline cellulose) tablet on randomisation and then rosuvastatin 20 mgs orally daily for 5 days with the first dose of drug commenced the next day after randomisation.
Control group
Dose comparison

Outcomes
Primary outcome [1] 288571 0
Myocardial Infarction (MI) size will be assessed by Cardiac Magnetic Resonance (CMR) late gadolinium enhancement
Timepoint [1] 288571 0
One CMR performed at days 4-6 post MI
Secondary outcome [1] 300481 0
Procedural success as assessed by coronary angiographic flow indices including Thrombolysis In Myocardial Infarction (TIMI) flow grade, corrected TIMI frame count (cTFC), and myocardial blush grade (MBG) in the infarct-related artery and cTFC in the non-infarct related artery.
Timepoint [1] 300481 0
Baseline at the time of the angioplasty.
Secondary outcome [2] 300482 0
Incidence and magnitude of CMR defined microvascular obstruction (MVO) and intramyocardial haemorrhage (IMH)
Timepoint [2] 300482 0
Assessed by CMR completed once at 4-6 days post MI
Secondary outcome [3] 300483 0
Incidence of clinical events (death, MI, target vessel revasularization)
Timepoint [3] 300483 0
30 days post randomisation

Eligibility
Key inclusion criteria
Symptoms of acute myocardial infarction within 12 hours with ST elevation of more than 1 mm in at least two contigous leads on ECG of new onset Left Bundle Branch Block.
Provision of written informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mm Hg
Previous MI
Standard CMR contraindications (e.g. pacemaker, severe claustrophobia etc.)
Known serious or hypersensitivity reactions to statin
known familial hypercholesterolemia
known active liver disease or significant renal failure (eGFR < 45 mls/min)
Non-cardiac comorbidity with life expectation < 1 year.
Patients who are Filipino, Chinese, Japanese, Korean or Vietnamese.
Patients taking any of the following cyclosporine, gemfibrozel or fusidic acid.
Attending consultant intends to use high dose statin therapy, Atorvastatin 80 mgs or Rosuvastatin 40 mgs.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 353 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 354 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 355 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [4] 356 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 357 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 6145 0
5042 - Bedford Park
Recruitment postcode(s) [2] 6146 0
5001 - Adelaide
Recruitment postcode(s) [3] 6147 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 6148 0
2065 - Royal North Shore Hospital
Recruitment postcode(s) [5] 6149 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 286511 0
Other
Name [1] 286511 0
South Australian Health and Medical Research Institute (SAHMRI)
Country [1] 286511 0
Australia
Primary sponsor type
Other
Name
SAHMRI
Address
Level 9, 121 King William Street, Po Box 11060,
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 285300 0
None
Name [1] 285300 0
Address [1] 285300 0
Country [1] 285300 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288586 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 288586 0
Flinders Medical Centre
The Flats G5 – Rooms 3 and 4
Flinders Drive
Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 288586 0
Australia
Date submitted for ethics approval [1] 288586 0
Approval date [1] 288586 0
19/12/2012
Ethics approval number [1] 288586 0
EC00188

Summary
Brief summary
The primary purpose of the study is to ascertain whether giving high doses of a cholesterol lowering drug (statin) can reduce the amount of damage caused to the heart by having a lack of oxygen and then having blood restored to the heart quickly when the blocked artery is opened by the insertion of a stent. Tissue damage may be caused when the supply of oxygen is restored to the heart. There are sound biological reasons but limited data that shows that by giving a high dose of a statin drug it is believed that the injury to the heart may be lessened and that incidences of heart failure caused by the heart attack may be lessened.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36810 0
Prof Joseph Selvanayagam
Address 36810 0
Department of Cardiovascular Medicine
Flinders Medical Centre
Flinders Drive
BEDFORD PARK SA 5042
Country 36810 0
Australia
Phone 36810 0
+61 8 8404 2195
Fax 36810 0
Email 36810 0
[email protected]
Contact person for public queries
Name 36811 0
Ms Christine Edwards
Address 36811 0
SAHMRI North Terrace, ADELAIDE, SA 5000
Country 36811 0
Australia
Phone 36811 0
+61 8 8128 4511
Fax 36811 0
Email 36811 0
[email protected]
Contact person for scientific queries
Name 36812 0
Prof Joseph Selvanayagam
Address 36812 0
Department of Cardiovascular Medicine
Flinders Medical Centre
Flinders Drive
BEDFORD PARK SA 5042
Country 36812 0
Australia
Phone 36812 0
+61 8 8404 2195
Fax 36812 0
Email 36812 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study withdrawn


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.