Blood thinners and cholesterol medicines to prevent future brain events in people with hidden (covert) brain infarcts
A EUROpean Pragmatic Multicenter Randomized Trial on Platelet Inhibition and/or Lipid Lowering Treatment in Covert Brain Infarction (CBI)
This trial will see if taking a blood thinner and/or a cholesterol‑lowering medicine lowers the chance of future stroke or dementia in people 50 and older who have MRI-detected covert brain infarcts but no prior stroke symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1652 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 14 sites (Aalborg and 13 other locations) |
| Trial ID | NCT07012629 on ClinicalTrials.gov |
What this trial studies
This is a randomized phase 3 trial enrolling people with MRI-confirmed covert brain infarcts who have not had prior stroke or TIA. Participants will be assigned to antiplatelet treatment (such as aspirin or clopidogrel) and/or statin therapy (such as rosuvastatin or atorvastatin) to compare vascular and cognitive outcomes versus usual care. The study will track major vascular events and measures of cognitive decline over follow-up to determine whether active prevention reduces future stroke and dementia risk. Sites are coordinated by Aarhus University Hospital with collaborating Danish centers.
Who should consider this trial
Good fit: Adults aged 50 or older with MRI evidence of a lacunar or cortical covert brain infarct, life expectancy over 12 months, and who are predominantly independent in daily activities (mRS ≤ 3) are ideal candidates.
Not a fit: People with prior symptomatic stroke or TIA, life expectancy ≤ 12 months, or significant disability (mRS > 3) are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If positive, the treatments could lower the risk of future stroke and possibly reduce the chance of developing dementia in people with covert brain infarcts.
How similar studies have performed: Antiplatelet agents and statins are proven to lower recurrent stroke risk in people with symptomatic cerebrovascular disease, but randomized evidence specifically targeting asymptomatic covert brain infarcts is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * MRI demonstrating a lacunar infarct (acute/subacute/chronic) without prior stroke/TIA symptoms. (A round or ovoid, subcortical, fluid-filled cavity (signal similar to cerebrospinal fluid (CSF)) between 3 and 15 mm in diameter and demonstrating a peripheral T2/FLAIR hyperintense rim of marginal gliosis. For infratentorial lesions the hyperintense rim may be less marked and a complete ring is not required) OR * MRI demonstrating a cortical infarct (acute/subacute/chronic) without prior stroke/TIA symptoms (A cortical infarct is defined as a fluid-filled cavity (signal similar to CSF) in the cortex, juxtacortical region or cerebellar cortex and with a ring of T2/FLAIR hyperintense lesions or as cortical T2/FLAIR lesions without a fluid-filled cavity with presumed vascular origin. Both supra- and infratentorial lesion will be included) AND Life expectancy \> 12 months AND Predominantly independent in actives of daily living (mRS score ≤ 3) AND Age ≥ 50 years Exclusion Criteria: * History of stroke/TIA * High risk of bleeding (e.g., recent or recurrent gastrointestinal or genitourinary bleeding associated with a decrease in hemoglobin levels of at least 1 mmol/L, active peptic ulcer disease, MRI with cortical siderosis and/or prior lobar hemorrhage) * Indication for long-term use of anticoagulants (e.g. deep vein thrombosis, pulmonary embolism, atrial fibrillation, and rarer indications; such as mechanical heart valve, antiphospholipid antibody syndrome etc.) * Concurrent indication for lipid-lowering treatment and/or platelet-inhibitors for secondary cardiovascular prevention (ischemic heart disease, recent stenting, ischemic stroke, revascularization surgeries, lower-extremity atherosclerotic arterial disease etc.) * Co-existing progressive neurodegenerative disease including dementia or Parkinson's disease. * Neoplastic condition that is uncontrolled or associated with an increased risk of bleeding * Patient already on antiplatelet or anticoagulation agent, regardless of indication * Women with a history of menopause below 12 months are only included after negative pregnancy test
Where this trial is running
Aalborg and 13 other locations
- Aalborg Universitetshospital — Aalborg, Denmark (Not_yet_recruiting)
- Aarhus Universitetshospital — Aarhus, Denmark (Not_yet_recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Not_yet_recruiting)
- Bispebjerg og Frederiksberg Hospital — Copenhagen, Denmark (Not_yet_recruiting)
- Herlev Hospital — Herlev, Denmark (Not_yet_recruiting)
- Regionshospitalet Gødstrup — Herning, Denmark (Not_yet_recruiting)
- Kolding Hospital — Kolding, Denmark (Not_yet_recruiting)
- Odense Universitetshospital — Odense, Denmark (Not_yet_recruiting)
- Roskilde Hospital — Roskilde, Denmark (Not_yet_recruiting)
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (Not_yet_recruiting)
- Oslo University Hospital — Oslo, Norway (Not_yet_recruiting)
- Skånes Universitetssjukhus — Lund, Sweden (Not_yet_recruiting)
- Universitätsspital - Inselspital - University of Bern — Bern, Switzerland (Not_yet_recruiting)
Study contacts
- Study coordinator: Rolf Blauenfeldt
- Email: rolfblau@rm.dk
- Phone: +4529318244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.