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Trial registered on ANZCTR


Trial ID
ACTRN12605000170628
Ethics application status
Approved
Date submitted
15/08/2005
Date registered
17/08/2005
Date last updated
24/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute Stroke Treatment with Atorvastatin and Irbesartan
Scientific title
A placebo controlled study to test the effectiveness of atorvastatin and irbesartan on infarct size, cerebral perfusion, cerebral response to ischaemia and clinical outcome in acute ischaemic stroke
Secondary ID [1] 119 0
2004/085
Universal Trial Number (UTN)
Trial acronym
ASTART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischaemic Stroke 265 0
Condition category
Condition code
Stroke 298 298 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30 days Atorvastatina 80 mg and Irbesartan 150 mg
2x2 factorial design
Intervention code [1] 191 0
Treatment: drugs
Comparator / control treatment
Placebo - empty matching capsules daily for 30 days
Control group
Placebo

Outcomes
Primary outcome [1] 350 0
Infarct Size
Timepoint [1] 350 0
At day 30
Primary outcome [2] 351 0
Perfusion abnormality
Timepoint [2] 351 0
At day 3
Secondary outcome [1] 791 0
Markers of inflammation and vascular function (CRP, vWF, fibrinogen, E selectin, plasma isoprostanes).
Timepoint [1] 791 0
At day 3 and day 30
Secondary outcome [2] 792 0
Brain injury (S100B) and clinical outcome (MRS, MBS, NIHSS, MMSE).
Timepoint [2] 792 0
At day 3 and day 30

Eligibility
Key inclusion criteria
All patients admitted within 72 hours of onset of symptoms will be eligible for trial entry, unless exclusion criteria are met.If a person is unable to provide informed consent the next of kin will be sought to provide consent. Patients regaining capacity will be free to continue in or withdraw from the trial.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hypotension: Blood pressure less than 100mmHg systolic or 70mmHg diastolic. Hypertension (>220 mmHg) or clinical imperative to lower blood pressure. Hyperkalaemia: >5.5 mmol/L. Finger prick or laboratory blood sugar level > 13 mmol/L at baseline. Acute comorbid condition (such as myocardial ischaemia or sepsis). Active liver disease or unexplained elevation in transaminases. Already treated with ATRA, statin or more than one of an ACE inhibitor, non steroidal anti-inflammatory, potassium sparing diuretic, potassium salt or cyclosporin. Premenopausal female. Renal impairment (defined as creatinine >120 umol/L). History of sensitivity to statins, ATRA or contrast. Haemorrhage seen on initial CT.

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)
Concealed (randomisation table held by pharmacy)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence stratified by time to event
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 356 0
University
Name [1] 356 0
University of Western Australia
Address [1] 356 0
Stirling Hwy CRAWLEY WA 6009
Country [1] 356 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Stirling Hwy CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 282 0
None
Name [1] 282 0
None
Address [1] 282 0
Country [1] 282 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1328 0
Royal Perth Hospital
Ethics committee address [1] 1328 0
Ethics committee country [1] 1328 0
Australia
Date submitted for ethics approval [1] 1328 0
Approval date [1] 1328 0
Ethics approval number [1] 1328 0
Ethics committee name [2] 1329 0
Sir Charles Gairdner Hospital
Ethics committee address [2] 1329 0
Ethics committee country [2] 1329 0
Australia
Date submitted for ethics approval [2] 1329 0
Approval date [2] 1329 0
Ethics approval number [2] 1329 0

Summary
Brief summary
The study aims to examine the effect of early treatment of acute ischaemic stroke with an ATRA and statin on surrogate markers of clinical outcome comprising the local response to ischaemia, cerebral blood flow, infarct growth and recurrent cardiovascular events.
Trial website
Trial related presentations / publications
Beer C, Blacker D, Bynevelt M, Hankey GJ and Puddey IB. A Randomised Placebo Controlled Trial of Early Treatment of Acute Ischaemic Stroke with Atorvastatin and Irbesartan. Int J Stroke 2011; 7:104-111
Public notes

Contacts
Principal investigator
Name 35467 0
Address 35467 0
Country 35467 0
Phone 35467 0
Fax 35467 0
Email 35467 0
Contact person for public queries
Name 9380 0
Christopher Beer
Address 9380 0
Geriatric Medicine
University of Western Australia
Level 6
Ainslie House
48 Murray St
Perth WA 6000
Country 9380 0
Australia
Phone 9380 0
+61 8 92242750
Fax 9380 0
+61 8 92242063
Email 9380 0
cdbeer@graduate.uwa.edu.au
Contact person for scientific queries
Name 308 0
Christopher Beer
Address 308 0
Geriatric Medicine
University of Western Australia
Level 6
Ainslie House
48 Murray St
Perth WA 6000
Country 308 0
Australia
Phone 308 0
+61 8 92242750
Fax 308 0
+61 8 92242063
Email 308 0
cdbeer@graduate.uwa.edu.au