None listed
Conditions
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.
Interventions
30 days Atorvastatina 80 mg and Irbesartan 150 mg
2x2 factorial design
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed