Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000175673
Ethics application status
Approved
Date submitted
15/08/2005
Date registered
19/08/2005
Date last updated
23/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
INFLAMMATION and VASCULAR FUNCTION in ACUTE STROKE and TIA: TREATMENT WITH ATORVASTATIN and IRBESARTAN
Scientific title
INFLAMMATION and VASCULAR FUNCTION in ACUTE STROKE and TIA: TREATMENT WITH ATORVASTATIN and IRBESARTAN
Secondary ID [1] 120 0
2004/085
Universal Trial Number (UTN)
Trial acronym
VCAPS-T
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischaemic Stroke 270 0
Transient Ischaemic Attack 271 0
Condition category
Condition code
Stroke 305 305 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Atorvastatin 80mg or Irbesartan 150mg for 21 days
Intervention code [1] 194 0
Treatment: Drugs
Comparator / control treatment
Placebo - matching empty oral capsules for 30 days
Control group
Placebo

Outcomes
Primary outcome [1] 358 0
Inflammation (measured with FDG-PET, CRP and fibrinogen)
Timepoint [1] 358 0
At baseline and day 21.
Primary outcome [2] 359 0
Oxidative stress (F2-isoprostanes)
Timepoint [2] 359 0
At baseline and day 21.
Primary outcome [3] 360 0
Vascular function (20-HETE excretion and forearm vascular function)
Timepoint [3] 360 0
At baseline and day 21.
Secondary outcome [1] 806 0
Effect of treatment with 21 days of atorvastatin or irbesartan on primary outcome measures.
Timepoint [1] 806 0
21 days

Eligibility
Key inclusion criteria
Patients presenting to facilities of the North Metropolitan Area Health Service within 10 days of acute ischaemic stroke.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Finger prick or laboratory blood sugar level > 13 mmol/L at baseline; - Acute co morbid condition (such as myocardial ischaemia or sepsis); - Pre-menopausal female; - Haemorrhage seen on initial CT.Statin exclusion criteria: - History of sensitivity to statins; - Active liver disease or unexplained elevation in transaminasesIrbesartan exclusion criteria: - Hypotension (SBP< 100mmHg or DBP<70mmHg); - Hypertension (>220 mmHg) or clinical imperative to lower blood pressure hyperkalaemia: >5.5 mmol/L; - History of sensitivity to ATRA; - Renal impairment (defined as creatinine >120 umol/L); - Current treatment with an ATRA or more than one of an ACE inhibitor, non steroidal anti-inflammatory, potassium sparing diuretic, potassium salt or cyclosporin.

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 prior therapy.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 361 0
University
Name [1] 361 0
University of Weatern Australia
Country [1] 361 0
Australia
Funding source category [2] 362 0
Other
Name [2] 362 0
Grants
Country [2] 362 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Hwy CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 287 0
None
Name [1] 287 0
None
Address [1] 287 0
Country [1] 287 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35900 0
Address 35900 0
Country 35900 0
Phone 35900 0
Fax 35900 0
Email 35900 0
Contact person for public queries
Name 9383 0
Christopher Beer
Address 9383 0
Level 6
Ainslie House
48 Murray St
Perth WA 6000
Country 9383 0
Australia
Phone 9383 0
+61 8 92242750
Fax 9383 0
+61 8 92242063
Email 9383 0
cdbeer@graduate.uwa.edu.au
Contact person for scientific queries
Name 311 0
Christopher Beer
Address 311 0
Level 6
Ainslie House
48 Murray St
Perth WA 6000
Country 311 0
Australia
Phone 311 0
+61 8 92242750
Fax 311 0
+61 8 92242063
Email 311 0
cdbeer@graduate.uwa.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.