INFLAMMATION and VASCULAR FUNCTION in ACUTE STROKE and TIA: TREATMENT WITH ATORVASTATIN and IRBESARTAN

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12605000175673
• Date of registration: 19/08/2005
• Prospective Registration: No
• Primary sponsor: University of Western Australia
• 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
• Date of first enrolment: 01/05/2005
• Target sample size: 40
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12605000175673.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety;
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Christopher Beer

• Name: Christopher Beer

Key inclusion & exclusion criteria

Inclusion criteria: Patients presenting to facilities of the North Metropolitan Area Health Service within 10 days of acute ischaemic stroke.
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.

Age minimum: Not stated
Age maximum: Not stated
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Acute Ischaemic Stroke ;Transient Ischaemic Attack;
Acute Ischaemic Stroke
Transient Ischaemic Attack

Stroke - Ischaemic

Intervention(s)

Atorvastatin 80mg or Irbesartan 150mg for 21 days

Primary Outcome(s)

Oxidative stress (F2-isoprostanes)[At baseline and day 21.]

Vascular function (20-HETE excretion and forearm vascular function)[At baseline and day 21.]

Inflammation (measured with FDG-PET, CRP and fibrinogen)[At baseline and day 21.]

Secondary Outcome(s)

Effect of treatment with 21 days of atorvastatin or irbesartan on primary outcome measures.[21 days]

Secondary ID(s)

2004/085

Source(s) of Monetary Support

Grants

University of Weatern Australia