NCT07012629

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,652 (estimated)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Magnetic resonance imaging (MRI) is commonly used in healthcare, and sometimes it shows small areas of brain damage called Covert Brain Infarcts (CBIs). These are usually found by chance when people have scans for things like headaches or dizziness. Although CBIs don't cause symptoms at the time, they are linked to a higher risk of future stroke and death. There is currently no standard treatment for CBIs, and doctors have different approaches-some give stroke-preventing medication (like antiplatelets or statins), while others don't treat at all. This is mostly because there isn't enough research yet. This study will test whether stroke-preventing treatments help people with CBIs. It will also look at whether having a CBI increases the risk of dementia, and whether treatment might lower that risk.

Conditions

• Covert Brain Infarction

Interventions

Type	Name	Description
DRUG	acetylsalicyclic acid (ASA)	Daily dose 75 mg to 100 mg p.o.
DRUG	Clopidogrel	Daily dose 75 mg p.o.
DRUG	Rosuvastatin	Daily dose 20 mg p.o. (10 mg once daily for the first 4 weeks, then 20 mg once daily for the remainder of the study period if tolerated). If Rosuvastatin 20 mg is not tolerated, a dose reduction to 10 mg is allowed.
DRUG	Atorvastatin	Daily dose 40 mg p.o. If Atorvastatin 40 mg is not tolerated, a dose reduction to 20 mg is allowed.

Timeline

• Start date: 2025-11-26
• Primary completion: 2031-09-30
• Completion: 2040-01-01
• First posted: 2025-06-10
• Last updated: 2025-12-04

Locations

14 sites across 5 countries: Denmark, Germany, Norway, Sweden, Switzerland