A study of drug combination (clopidogrel, acetylsalicylic acid, atorvastatin, rosuvastatin) for patients with covert brain infarction

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What is this study about?

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.

1 Initial assessment and study start

Your participation begins with a brain MRI scan that shows small areas of damage (infarcts) that haven’t caused noticeable symptoms

Medical staff will perform initial evaluations including physical activity questionnaire, quality of life assessment, and cognitive function tests

You will receive a frailty assessment and evaluation of your daily activities abilities

2 Treatment phase start

You will be assigned to receive one or more of these medications taken by mouth:

– Clopidogrel (blood thinning medication)

– Atorvastatin or Rosuvastatin (cholesterol-lowering medications)

– Acetylsalicylic acid (aspirin)

The specific combination will be determined by the study protocol

3 12-month follow-up

Assessment of your daily activities ability

Evaluation of your general health condition

Quality of life questionnaire completion

Physical activity level assessment

Cognitive function testing

4 36-month (final) evaluation

Final brain MRI scan to check for any changes

Complete set of assessments including:

– Daily activities ability evaluation

– Quality of life questionnaire

– Physical activity assessment

– Cognitive function testing

– General health condition evaluation

Who Can Join the Study?

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 Study?

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

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Lillebaelt Hospital	Kolding	Denmark
Aalborg University Hospital	Aalborg	Denmark
Hjgywn Hncpezuw	Herlev	Denmark
Axagzi Uuhquwirln Hcaxfapt	Aarhus	Denmark
Rzvwwf Moisaaqofan	Herning	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.09.2025

Trial locations

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).

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 ID:

2025-521452-30-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study of drug combination (clopidogrel, acetylsalicylic acid, atorvastatin, rosuvastatin) for patients with covert brain infarction

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?