A multi-centre, randomised, double-blind, placebo controlled trial of the effects of 100mg enteric-coated aspirin on rate of increase of magnetic resonance imaging(MRI)-based white matter hyperintensity (WMH) and silent brain infarction (SBI).

Australian National University (ANU)0 个研究点目标入组 600 人开始时间: 2009年7月22日最近更新: 2020年1月13日

试验速览

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•All subjects will be aged 70 years or more and capable of attending their usual family physician's clinic, providing informed consent and have no known contraindications to MRI.

•1. A history of cardiovascular morbidity defined as myocardial infarction, stroke, peripheral vascular disease, angina, transient ischaemic attack, greater than 50% carotid stenosis or previous carotid endarterectomy or stenting, coronary artery angioplasty or stenting, or coronary artery bypass grafting
•2. A serious intercurrent illness likely to cause death within the next 5 years
•3. A current or recurrent condition with a high risk of major bleeding e.g. cerebral aneurysm or cerebral arteriovenous (AV) malformation, any bleeding diathesis, gastrointestinal malignancy, peptic ulcer, liver disease, uraemia, aortic aneurysm or any other condition known to be associated with a high risk of serious bleeding
•4. Absolute contraindication or allergy to aspirin
•5. Current participation in a clinical trial
•6. Current continuous use of aspirin or other anti-platelet drug or anticoagulant
•7. A history of dementia
•8. In addition those who lie outside of tolerance levels of 8-104% during placebo run-in phase will not be randomised
•9. An inability to perform independently one of the 6 Katz Activities of Daily Living (walking, bathing, dressing, transferring from chair or bed, toileting, eating)
•10. Pill taking compliance below 80% on tablet count during a placebo run-in phase
•11. Absolute contraindications to undergo MRI

发起方

Australian National University (ANU)