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Silent brain infarcts: new trial tests aspirin and statins to prevent stroke and dementia

NCT ID NCT07012629

Disease control Sponsor: Aarhus University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether common stroke-preventing medications—aspirin, clopidogrel, and statins—can reduce the risk of future stroke, heart attack, and dementia in people who have small, symptomless areas of brain damage called covert brain infarcts (CBIs). These are often found by chance on MRI scans. The trial will enroll about 1,650 participants across Europe and follow them for up to 3 years to see if treatment lowers the chance of major cardiovascular events and dementia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aspirin, clopidogrel, rosuvastatin, or atorvastatin
What this could lead to
If successful, this could establish a standard treatment to prevent future strokes and dementia in people with silent brain infarcts.
What could go wrong
This is a large phase 3 trial, but the benefit of these medications for silent brain infarcts is unproven. There is a risk of bleeding or other side effects from the drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,652 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2040

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cerebral infarction dementia MRI defined brain infarct stroke disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Covert brain infarction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aalborg Universitetshospital

    NOT_YET_RECRUITING

    Aalborg, 9000, Denmark

  • Aarhus Universitetshospital

    NOT_YET_RECRUITING

    Aarhus, 8200, Denmark

  • Aarhus University Hospital

    RECRUITING

    Aarhus, 8200, Denmark

  • Bispebjerg og Frederiksberg Hospital

    NOT_YET_RECRUITING

    Copenhagen, 2400, Denmark

  • Herlev Hospital

    NOT_YET_RECRUITING

    Herlev, 2730, Denmark

  • Kolding Hospital

    NOT_YET_RECRUITING

    Kolding, 6000, Denmark

  • Odense Universitetshospital

    NOT_YET_RECRUITING

    Odense, 5000, Denmark

  • Oslo University Hospital

    NOT_YET_RECRUITING

    Oslo, 0450, Norway

  • Regionshospitalet Gødstrup

    NOT_YET_RECRUITING

    Herning, 7400, Denmark

  • Rigshospitalet

    NOT_YET_RECRUITING

    Copenhagen, 2100, Denmark

  • Roskilde Hospital

    NOT_YET_RECRUITING

    Roskilde, 4000, Denmark

  • Skånes Universitetssjukhus

    NOT_YET_RECRUITING

    Lund, 22242, Sweden

  • University Medical Center Hamburg-Eppendorf

    NOT_YET_RECRUITING

    Hamburg, 20246, Germany

  • Universitätsspital - Inselspital - University of Bern

    NOT_YET_RECRUITING

    Bern, 3010, Switzerland