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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-26

Study Completion Date

2040-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Covert Brain Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2x2 factorial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A: Platelet inhibitor - no Statin ("APT alone")

All patients will initiate treatment with Aspirin or Clopidogrel. The decision on which of the two drugs to initiate is at the discretion of the treating physician/center.

Group Type EXPERIMENTAL

acetylsalicyclic acid (ASA)

Intervention Type DRUG

Daily dose 75 mg to 100 mg p.o.

Clopidogrel

Intervention Type DRUG

Daily dose 75 mg p.o.

Group B: Statins - no Platelet inhibitor ("Statin alone").

Patients will be treated with high-intensity statin therapy (Atorvastatin 40 mg once daily or Rosuvastatin 20 mg once daily)

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

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.

Atorvastatin

Intervention Type DRUG

Daily dose 40 mg p.o. If Atorvastatin 40 mg is not tolerated, a dose reduction to 20 mg is allowed.

Group C: Statins - Platelet inhibitor ("APT AND statin")

Both types of medication are initiated as described in group A and B

Group Type EXPERIMENTAL

acetylsalicyclic acid (ASA)

Intervention Type DRUG

Daily dose 75 mg to 100 mg p.o.

Clopidogrel

Intervention Type DRUG

Daily dose 75 mg p.o.

Rosuvastatin

Intervention Type DRUG

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.

Atorvastatin

Intervention Type DRUG

Daily dose 40 mg p.o. If Atorvastatin 40 mg is not tolerated, a dose reduction to 20 mg is allowed.

Group D: No Statins - no Platelet inhibitor (current standard treatment)

This group follows the current European recommendations of primary prevention which do not include statins and APT agents. If statins and/or platelet inhibitors are started during the study-period it should adhere to primary prevention guidelines.

All four groups receive advice on lifestyle optimization and blood pressure management.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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acetylsalicyclic acid (ASA)

Daily dose 75 mg to 100 mg p.o.

Intervention Type DRUG

Clopidogrel

Daily dose 75 mg p.o.

Intervention Type 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.

Intervention Type DRUG

Atorvastatin

Daily dose 40 mg p.o. If Atorvastatin 40 mg is not tolerated, a dose reduction to 20 mg is allowed.

Intervention Type DRUG

Other Intervention Names

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Aspirin

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Rolf Blauenfeldt

MD, PhD, Associate professor of Neurology.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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