Recruiting PHASE3 Covert Brain Infarction

New treatment option for Covert Brain Infarction

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)

ClinicalTrials.gov ID: NCT07012629

What this study is testing

What is acetylsalicyclic acid (ASA)?

acetylsalicyclic acid (ASA) is an investigational medicine, given as an once-daily, being studied as a potential treatment for covert brain infarction.

Also referred to as Aspirin.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 50 and older

You may be able to join if

  • MRI demonstrating a lacunar infarct (acute/subacute/chronic) without prior stroke/TIA symptoms. (A round or ovoid, subcortical, fluid-filled cavity...
  • MRI demonstrating a cortical infarct (acute/subacute/chronic) without prior stroke/TIA symptoms (A cortical infarct is defined as a fluid-filled...

You likely can't join if

  • 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...
  • Indication for long-term use of anticoagulants (e.g. deep vein thrombosis, pulmonary embolism, atrial fibrillation, and rarer indications; such as...
  • Concurrent indication for lipid-lowering treatment and/or platelet-inhibitors for secondary cardiovascular prevention (ischemic heart disease, recent...
  • Co-existing progressive neurodegenerative disease including dementia or Parkinson's disease.
  • Neoplastic condition that is uncontrolled or associated with an increased risk of bleeding
See the full eligibility criteria
Who can join
  • 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...
  • 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...
What rules you out
  • 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...
  • 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...
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Aalborg, Denmark
  • Aarhus, Denmark
  • Copenhagen, Denmark
  • Herlev, Denmark
  • Herning, Denmark
  • Kolding, Denmark
  • Odense, Denmark
  • Roskilde, Denmark
  • Hamburg, Germany
  • Oslo, Norway
  • Lund, Sweden
  • Bern, Switzerland

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Aalborg, Denmark; Aarhus, Denmark; Copenhagen, Denmark; Herlev, Denmark; Herning, Denmark; Kolding, Denmark and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.