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A EUROpean Pragmatic Multicenter Randomized Trial on Platelet Inhibition and/or Lipid Lowering Treatment in Covert Brain Infarction (CBI)

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aalborg Universitetshospital
NOT_YET_RECRUITING
Aalborg
Aarhus Universitetshospital
NOT_YET_RECRUITING
Aarhus
Aarhus University Hospital
RECRUITING
Aarhus
Bispebjerg og Frederiksberg Hospital
NOT_YET_RECRUITING
Copenhagen
Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Herlev Hospital
NOT_YET_RECRUITING
Herlev
Regionshospitalet Gødstrup
NOT_YET_RECRUITING
Herning
Kolding Hospital
NOT_YET_RECRUITING
Kolding
Odense Universitetshospital
NOT_YET_RECRUITING
Odense
Roskilde Hospital
NOT_YET_RECRUITING
Roskilde
Germany
University Medical Center Hamburg-Eppendorf
NOT_YET_RECRUITING
Hamburg
Norway
Oslo University Hospital
NOT_YET_RECRUITING
Oslo
Sweden
Skånes Universitetssjukhus
NOT_YET_RECRUITING
Lund
Switzerland
Universitätsspital - Inselspital - University of Bern
NOT_YET_RECRUITING
Bern
Contact Information
Primary
Rolf Blauenfeldt
rolfblau@rm.dk
+4529318244
Backup
Ida Thingholm Norup
idnoru@rm.dk
+4520848978
Time Frame
Start Date: 2025-11-26
Estimated Completion Date: 2040-01-01
Participants
Target number of participants: 1652
Treatments
Experimental: 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.
Experimental: 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)
Experimental: Group C: Statins - Platelet inhibitor (APT AND statin)
Both types of medication are initiated as described in group A and B
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Bispebjerg Hospital, University Medical Center Hamburg-Eppendorf (UKE), Gødstrup Hospital, Zealand University Hospital, Lund University Hospital, Odense University Hospital, Oslo University Hospital, Insel Gruppe AG, University Hospital Bern, Aalborg University Hospital, Herlev Hospital, Rigshospitalet, Denmark
Leads: Aarhus University Hospital

This content was sourced from clinicaltrials.gov