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

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

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.

Sponsors & Collaborators

• Rigshospitalet, Denmark

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• University Medical Center Hamburg-Eppendorf (UKE)

  collaborator UNKNOWN

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• Lund University Hospital

  collaborator OTHER

• Aarhus University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-26

Primary Completion

2031-09-30

Completion

2040-01-01

Countries

• Denmark
• Germany
• Norway
• Sweden
• Switzerland

Study Locations