Acute Stroke Treatment with Atorvastatin and irbesaRTan (ASTART)

Stroke is the second leading cause of global mortality, and is a major contributor to the burden of disease in Australia. Following a Transient Ischaemic Attack (TIA or 'mini-stroke') or stroke, about 10% of patients experience another TIA or stroke event within the first week, and 20% within the first 90 days. At 6 months after stroke, more than 60% of patients will have died or be dependent despite current best medical therapy. The cost of stroke is therefore high both to individuals and to the community as a whole.

Following a stroke there is usually an area of brain tissue that is injured but may potentially recover. This is the area of brain targeted with acute stroke treatments. Treatment also aims to reduce the high risk of recurrent disease. There is increasing evidence that medicines used to lower blood pressure (angiotensin receptor blockers) and cholesterol ('statins') may be helpful following stroke. However, we have previously not used these drugs in the acute phase following a stroke because of concerns about side effects. There is still concern that the cholesterol and blood pressure lowering effect of these drugs may be harmful in the acute phase of a stroke so use outside of a clinical trial is not recommended.

The ASTART study will investigate the treatment of acute stroke with an angiotensin receptor blocker (irbesartan) and a statin (atorvastatin). All patients admitted with a clinical diagnosis of acute ischaemic stroke will be screened for enrolment. Patients will be eligible for trial entry up to 72 hours after admission. Patients will be randomised to acute treatment with the combination of atorvastatin (80mg) and irbesartan (150mg), atorvastatin (80mg) alone, irbesartan (150mg) alone or placebo. The length of treatment will be thirty days. Continuation of irbesartan or atorvastatin therapy at the end of the study will be at the discretion of the attending physician and determined for each patient by established clinical indications for such therapy. Effect of the interventions on brain blood flow and damage to the brain (seen on head scans) will be the primary outcomes. Secondary outcomes will be recurrent vascular events (such as stroke and heart attack), and blood tests assessing inflammation, brain injury and blood vessel function.