Aalborg University Hospital
Verified
Aalborg, Denmark
Recruiting
A study of drug combination (clopidogrel, acetylsalicylic acid, atorvastatin, rosuvastatin) for patients with covert brain infarction
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study focuses on covert brain infarction, also known as asymptomatic brain infarctions, which are small areas of brain damage that can be seen on brain scans but do not cause noticeable symptoms. The study will test whether using blood-thinning and cholesterol-lowering medications can help prevent future health problems in people who have these silent brain changes.
The medications being studied include clopidogrel (a blood-thinning medication), acetylsalicylic acid (also known as aspirin), and two types of cholesterol-lowering medications called atorvastatin and rosuvastatin. The purpose is to determine if these treatments, along with managing other health risk factors, can reduce the risk of serious heart and brain problems over a three-year period.
During the study, participants will take their assigned medications daily and undergo various health assessments. These will include MRI scans of the brain to check for changes, tests of memory and thinking abilities, and evaluations of daily functioning and quality of life. The study will track any heart problems, strokes, or bleeding issues that occur during the treatment period.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
7 criteria
- Age 50 years or older
- Must have evidence of brain infarcts (areas of damaged brain tissue) on MRI scan without having experienced previous stroke symptoms. These can be either:
- Deep brain infarcts (3-15 mm in size) appearing as fluid-filled areas, or
- Cortical infarcts (affecting the outer layer of the brain)
- Must be mostly independent in daily activities (mRS score of 3 or less - meaning able to walk without assistance but may need some help with daily activities)
- Must have a life expectancy greater than 12 months
- Must be able to undergo MRI scanning (Magnetic Resonance Imaging - a medical imaging technique that uses magnetic fields to create detailed images of the brain)
- Can be either male or female
Who cannot join the trial?
15 criteria
- History of stroke symptoms or previous clinical diagnosis of stroke
- Current use of blood-thinning medications (anticoagulants or antiplatelets)
- Active or recent major bleeding within the past 6 months
- Known bleeding disorders or conditions that increase bleeding risk
- Severe liver disease that affects blood clotting
- Planned surgery within the next 3 months
- Allergic reactions to antiplatelet medications or statins
- Pregnancy or planning to become pregnant during the study period
- Participation in other clinical trials within the past 30 days
- Inability to provide informed consent
- Life expectancy less than 3 years due to other medical conditions
- Uncontrolled high blood pressure (hypertension)
- History of intracranial hemorrhage (bleeding in the brain)
- Severe kidney disease requiring dialysis
- Active cancer requiring treatment
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Verified sites
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Herlev Hospital
VerifiedHerlev, DenmarkSykehuset Oestfold HF Kalnes
Responsive
Graalum, Norway
Trial locations
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Investigated drugs
Based on the provided trial information, the medications involved in this trial are:
Antiplatelet medications - These are medicines that help prevent blood clots by stopping blood cells called platelets from sticking together. They are commonly used to reduce the risk of heart attacks and strokes.
Statins - These are medications that help lower cholesterol levels in the blood. They work by reducing the amount of cholesterol your body makes, helping to prevent heart disease and stroke.
Note: While the trial mentions both types of medications, specific drug names are not provided in the source data. The study focuses on these two classes of medications for patients with covert brain infarctions (silent strokes).
What is already known about the treatment
Based on the provided clinical trial data, which focuses on platelet inhibition and lipid-lowering treatment for covert brain infarction, I'll describe the two main types of medications involved:
Antiplatelet medications - A class of drugs taken orally that work by preventing blood platelets from sticking together, thus reducing the risk of blood clot formation in the arteries and veins. These medications are widely used in cardiovascular and cerebrovascular medicine to prevent strokes and heart attacks. The mechanism of action involves blocking specific receptors on platelets or inhibiting enzymes that promote platelet aggregation, making them essential in the prevention of vascular events in patients with covert brain infarctions.
Statins - A group of lipid-lowering medications taken orally that reduce cholesterol levels in the blood by inhibiting an enzyme called HMG-CoA reductase, which plays a central role in cholesterol production in the liver. These drugs are well-established in medical practice for preventing cardiovascular events and are considered a standard treatment for reducing the risk of stroke and heart disease. Statins not only lower cholesterol levels but also have anti-inflammatory properties that may provide additional protection against vascular events.
Investigated diseases
Covert Brain Infarction
A type of stroke that occurs without noticeable symptoms, also known as silent cerebral infarction. It involves small areas of damage in the brain tissue caused by insufficient blood supply. These infarctions are typically discovered accidentally during brain imaging for other reasons. Over time, multiple covert brain infarctions can accumulate, potentially affecting cognitive function and brain health. The condition is more common in older adults and people with cardiovascular risk factors.
Dementia
A group of conditions characterized by a decline in cognitive function severe enough to affect daily life. The condition involves progressive loss of memory, thinking skills, and ability to perform everyday activities. It affects multiple areas of brain function, including memory, language, problem-solving, and attention. Dementia develops gradually and tends to become more severe over time.
Cerebral Small Vessel Disease
A condition affecting the small blood vessels in the brain, causing changes to the brain's white matter and small, deep areas of the brain. It develops slowly over time and can lead to changes in thinking abilities and movement. The disease affects the brain's blood circulation through small arteries and capillaries. It is commonly found in aging brains and in people with cardiovascular risk factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521452-30-01Estimated enrolment1 502 patientsSponsorRegion Midtjylland
sourced from the EU Clinical Trials Register and site verification
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