A European Pragmatic Multicenter Randomized Trial on Platelet Inhibition and/or Lipid Lowering Treatment in Covert Brain Infarction (CBI)

What this Trial Is About

Researchers are investigating treatments for people with small, unnoticed brain injuries called Covert Brain Infarcts (CBIs), which are often found by chance during MRI scans. CBIs do not cause symptoms initially but are linked to higher risks of stroke and death. The study aims to see if medications that prevent stroke, like blood thinners and cholesterol-lowering drugs, can help reduce these risks and whether CBIs increase the chance of dementia. Participants will be randomly assigned to one of four groups: one receiving a platelet inhibitor (either Aspirin or Clopidogrel) without statins, one receiving statin therapy (Atorvastatin or Rosuvastatin) without platelet inhibitors, one receiving both treatments, and one receiving neither treatment following current prevention guidelines. All groups will receive advice on lifestyle improvements and blood pressure management. Medication doses are carefully adjusted for tolerance, and the study follows a pragmatic, multicenter design. During the study, participants will be monitored for major cardiovascular and brain-related events, bleeding risks, dementia development, cognitive decline, and quality of life over 12 and 36 months. Assessments include MRI scans, physical activity levels, and various scales measuring daily living abilities, frailty, and neurological function. Researchers will also track serious adverse events and subtype characteristics of CBIs. The study duration spans at least three years with regular follow-ups to evaluate treatment effects and safety.

A EUROpean Randomized Study on Blood-thinners and Cholesterol-lowering Treatments to Prevent Future Vascular Events in People With Covert Brain Infarcts (CBI)