Blood thinners and cholesterol medicines to prevent future brain events in people with hidden (covert) brain infarcts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Aalborg Universitetshospital
  Aalborg, Denmark Not yet recruiting
• Aarhus Universitetshospital
  Aarhus, Denmark Not yet recruiting
• Rigshospitalet
  Copenhagen, Denmark Not yet recruiting
• Bispebjerg og Frederiksberg Hospital
  Copenhagen, Denmark Not yet recruiting
• Herlev Hospital
  Herlev, Denmark Not yet recruiting

Study contacts

• Study coordinator: Rolf Blauenfeldt
• Email: rolfblau@rm.dk
• Phone: +4529318244

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.