About EURO-CBI (ENG)
With easy access to brain imaging, an increasing number of patients undergo magnetic resonance imaging (MRI) of the brain. A very common problem occurs when radiologists diagnose covert brain infarcts (CBI), e.g. on scans ordered in the work up of headache or dizziness.
CBI are defined as focal cerebral lesions of presumed ischemic origin detected on MRI in patients without a fitting history of stroke or transient ischemic attack (TIA) and represent one of the most common incidental finding on brain MRI in clinical practice.
The majority are caused by asymptomatic cerebral small vessel disease. On T2-FLAIR (Fluid-Attenuated Inversion Recovery) MRI, a small round or ovoid, fluid-filled cavity usually with hyperintense rim of scaring (gliosis) can be seen. These are called lacunes and the appearance of CBIs do not differ from the lacunes seen in symptomatic small vessel disease, where the patient experiences a clinical stroke syndrome
CBIs are found in 10-30% of healthy elderly populations and in up to 50% of populations with increased cardiovascular risk factors and are frequently seen together with other markers of cerebral small vessel disease (cSVD).The lack of clinical manifestations in CBI might be related to their location in the brain, and CBIs are often located in non-eloquent areas of the brain (not controlling, e.g., speech, movement, or sensation) and in the right brain hemisphere (lack of symptom awareness).
Hypotesis
CBI confers a similar risk as a clinical stroke for recurrent ischemic events and death, and we aim to investigate whether addition of antithrombotic medication and/or cholesterol lowering medication in addition to risk factor management will provide a net long-term benefit in reducing vascular events and death at 3 years.
Design
Multicenter, randomized, 2x2 factorial, open-label, investigator initiated, pragmatic trial.
We plan to include 1652 patients with 413 in each group recruited from European stroke center
Participants
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≥50 years old
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MRI-confirmed covert lacunar and/or cortical infarct
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no prior symptoms of stroke or TIA.
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Functionally independent (mRS ≤3)
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Life expectancy >12 months
Without a high bleeding risk, dementia, or progressive cancer. Long-term anticoagulation, current antiplatelet use, or other contraindications exclude participation.
Primary endpoint
Vascular events (Major Adverse Cardiac and Cerebral Events, MACCE) and death at 3 years
