Actively Recruiting

Phase 3
Age: 50Years +
All Genders
NCT07012629

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

Led by Aarhus University Hospital · Updated on 2025-12-04

1652

Participants Needed

14

Research Sites

735 weeks

Total Duration

On this page

Sponsors

A

Aarhus University Hospital

Lead Sponsor

R

Rigshospitalet, Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • MRI shows a lacunar infarct without prior stroke or TIA symptoms, characterized by a specific fluid-filled brain lesion between 3 and 15 mm with certain MRI features, OR
  • MRI shows a cortical infarct without prior stroke or TIA symptoms, defined as a fluid-filled cavity or T2/FLAIR lesions with presumed vascular origin in cortical regions
  • Life expectancy greater than 12 months
  • Mostly independent in daily activities with a modified Rankin Scale (mRS) score of 3 or less
  • Age 50 years or older
Not Eligible

You will not qualify if you...

  • History of stroke or transient ischemic attack (TIA)
  • High risk of bleeding, including recent or recurrent gastrointestinal or genitourinary bleeding with significant hemoglobin drop, active peptic ulcer disease, or MRI evidence of cortical siderosis or prior lobar hemorrhage
  • Need for long-term anticoagulant use for conditions such as deep vein thrombosis, pulmonary embolism, atrial fibrillation, mechanical heart valve, or antiphospholipid antibody syndrome
  • Current need for lipid-lowering or platelet-inhibitor treatment for secondary cardiovascular prevention, including ischemic heart disease, recent stenting, ischemic stroke, revascularization surgeries, or lower-extremity arterial disease
  • Co-existing progressive neurodegenerative diseases including dementia or Parkinson's disease
  • Uncontrolled cancer or cancer associated with increased bleeding risk
  • Already taking antiplatelet or anticoagulant medications regardless of the reason
  • Women with menopause less than 12 months ago unless a negative pregnancy test has been confirmed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Aalborg Universitetshospital

Aalborg, Denmark, 9000

Not Yet Recruiting

2

Aarhus Universitetshospital

Aarhus, Denmark, 8200

Not Yet Recruiting

3

Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

4

Rigshospitalet

Copenhagen, Denmark, 2100

Not Yet Recruiting

5

Bispebjerg og Frederiksberg Hospital

Copenhagen, Denmark, 2400

Not Yet Recruiting

6

Herlev Hospital

Herlev, Denmark, 2730

Not Yet Recruiting

7

Regionshospitalet Gødstrup

Herning, Denmark, 7400

Not Yet Recruiting

8

Kolding Hospital

Kolding, Denmark, 6000

Not Yet Recruiting

9

Odense Universitetshospital

Odense, Denmark, 5000

Not Yet Recruiting

10

Roskilde Hospital

Roskilde, Denmark, 4000

Not Yet Recruiting

11

University Medical Center Hamburg-Eppendorf

Hamburg, Germany, 20246

Not Yet Recruiting

12

Oslo University Hospital

Oslo, Norway, 0450

Not Yet Recruiting

13

Skånes Universitetssjukhus

Lund, Sweden, 22242

Not Yet Recruiting

14

Universitätsspital - Inselspital - University of Bern

Bern, Switzerland, 3010

Not Yet Recruiting

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Research Team

R

Rolf Blauenfeldt

CONTACT

I

Ida Thingholm Norup

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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