Covert Brain InfarctionPhase 3EURO-CBINCT07012629
A EUROpean Randomized Study on Blood-thinners and Cholesterol-lowering Treatments to Prevent Future Vascular Events in People With Covert Brain Infarcts (CBI)
A Phase 3 study testing acetylsalicyclic acid (ASA), Clopidogrel and Rosuvastatin in people with Covert Brain Infarction, run by Aarhus University Hospital at 14 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Covert Brain Infarction
- What is being tested?
- acetylsalicyclic acid (ASA), Clopidogrel and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,652 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 26 Nov 2025to 1 Jan 2040
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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
Who cannot join
- 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 and/or prior lobar hemorrhage)
- 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, lower-extremity atherosclerotic arterial disease etc.)
- 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
Trial locations and contacts
14 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 5 countries
Denmark10 sites, 10 recruiting
- Not yet recruiting
Aalborg Universitetshospital
Aalborg, 9000
Boris Modrau, +4597662239, boris.modrau@rn.dk
- Not yet recruiting
Aarhus Universitetshospital
Aarhus, 8200
Claus Simonsen, +45 50240543, clausimo@rm.dk
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Rolf Blauenfeldt, +4529318244, rolfblau@rm.dk
- Not yet recruiting
Rigshospitalet
Copenhagen, 2100
Anders Sode West, +4538630220, anders.sode.west@regionh.dk
- Not yet recruiting
Bispebjerg og Frederiksberg Hospital
Copenhagen, 2400
Hanne Christensen, +4538635000, Hanne.Krarup.Christensen@regionh.dk
- Not yet recruiting
Herlev Hospital
Herlev, 2730
Anders Hougaard, +4538682790, anders.hougaard@regionh.dk
- Not yet recruiting
Regionshospitalet Gødstrup
Herning, 7400
Mohammed Ahmad Al-Jazi, +4578430000, moalja@rm.dk
- Not yet recruiting
Kolding Hospital
Kolding, 6000
Henrik Leth de Fønss, +4576302600, Henrik.Leth@rsyd.dk
- Not yet recruiting
Odense Universitetshospital
Odense, 5000
David Gaist, +4565504185, dgaist@health.sdu.dk
- Not yet recruiting
Roskilde Hospital
Roskilde, 4000
Troels Wienecke, +4547322808, trw@regionsjaelland.dk
Germany1 site, 1 recruiting
- Not yet recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Götz Thomalla, +4940741050137, thomalla@uke.de
Norway1 site, 1 recruiting
- Not yet recruiting
Oslo University Hospital
Oslo, 0450
Anne Hege Aamodt, +4795867270, a.h.aamodt@medisin.uio.no
Sweden1 site, 1 recruiting
- Not yet recruiting
Skånes Universitetssjukhus
Lund, 22242
Jesper Petersson, 0046406733000, Jesper.Petersson@skane.se
Switzerland1 site, 1 recruiting
- Not yet recruiting
Universitätsspital - Inselspital - University of Bern
Bern, 3010
Thomas Meinel, +41 76 4928 545, thomas.meinel@insel.ch
About this study
Official title: A EUROpean Pragmatic Multicenter Randomized Trial on Platelet Inhibition and/or Lipid Lowering Treatment in Covert Brain Infarction (CBI)
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
- Covert Brain Infarction
- Being tested
- acetylsalicyclic acid (ASA), Clopidogrel, Rosuvastatin, Atorvastatin
- Keywords
- CBI, Prevention, Asymptomatic brain infarction, Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicyclic acid (ASA)Drug
Also called Aspirin
Daily dose 75 mg to 100 mg p.o.
ClopidogrelDrug
Daily dose 75 mg p.o.
RosuvastatinDrug
Daily dose 20 mg p.o. (10 mg once daily for the first 4 weeks, then 20 mg once daily for the remainder of the study period if tolerated).
If Rosuvastatin 20 mg is not tolerated, a dose reduction to 10 mg is allowed.
AtorvastatinDrug
Daily dose 40 mg p.o. If Atorvastatin 40 mg is not tolerated, a dose reduction to 20 mg is allowed.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Platelet inhibitor - no Statin ("APT alone") | Experimental | 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. Receives: Drug: acetylsalicyclic acid (ASA); Drug: Clopidogrel |
| Group B: Statins - no Platelet inhibitor ("Statin alone"). | Experimental | Patients will be treated with high-intensity statin therapy (Atorvastatin 40 mg once daily or Rosuvastatin 20 mg once daily) Receives: Drug: Rosuvastatin; Drug: Atorvastatin |
| Group C: Statins - Platelet inhibitor ("APT AND statin") | Experimental | Both types of medication are initiated as described in group A and B Receives: Drug: acetylsalicyclic acid (ASA); Drug: Clopidogrel; Drug: Rosuvastatin; Drug: Atorvastatin |
| Group D: No Statins - no Platelet inhibitor (current standard treatment) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac and Cerebral Events (MACCE) at 12 and 36 months
MACCE are defined as the occurrence of any of the following events
- All cause death: Death from any cause
- Acute myocardial infarction: Admission with a discharge diagnosis of ST-elevation myocardial infarction (STEMI) and non-ST elevation myocardial infarction (NSTEMI) and
- Stroke: AIS* or Intracerebral hemorrhage (non-traumatic) *Including Transient Ischemic Attack (TIA) with evidence of brain tissue infarction i.e. remission of symptoms within 24 hours but who have an acute ischemic lesion on diffusion weighted imaging MRI.
All events qualifying for a MACCE event will be adjudicated by the Clinical event committee.
Accepted timeframe for evaluation is +/- 30 days
Measured: 12 months and 36 months post-randomization.
Major and fatal bleeding at 12 and 36 months
Major and fatal bleeding events are defined according to criteria established by the International Society on Thrombosis and Haemostasis (ISTH):
- Fatal bleeding, and/or
- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome, and/or
- Bleeding leading to a drop in hemoglobin of ≥20 g/L (1.24 mmol/L), or requiring transfusion of two or more units of whole blood or red cells.
All qualifying events will be adjudicated by an independent Clinical Event Committee (CEC).
The accepted time window for assessment is ±30 days.
Measured: 12 months and 36 months post-randomization.
Secondary outcomes (11)
All-cause dementia
Dementia is identified through phone contact and review of the patient's electronic health record, based on national diagnostic standards. Accepted diagnoses align with ICD-10 and ICD-11. ICD-10 codes include: dementia in Alzheimer's disease (F00.0-F00.9, DG30.0-DG30.9), vascular dementia (F01.0-F01.9, F00.2), dementia in other diseases classified elsewhere (F02.0-F02.8), unspecified dementia (F03.9), Lewy body dementia (DG31.8E), progressive isolated aphasia (DG31.0A), Pick disease (DG31.0B), and unspecified degenerative disease of the nervous system (DG31.9). ICD-11 codes include: dementia due to Alzheimer's disease (6D80), cerebrovascular disease (6D81), Lewy body disease (6D82), frontotemporal dementia (6D83), other specified diseases (6D85.Y), and dementia of unknown or unspecified cause (6D8Z). The accepted time window for evaluation is ±30 days.
Measured: 12 months and 36 months post-randomization.
Cardiovascular-related mortality
Information about cardiovascular mortality is collected from telephone contacts and from the patient's electronic health record. See the table below for the definition of cardiovascular mortality.
Cardiovascular Mortality are defined as:
- Acute MI
- Sudden cardiac death
- Heart failure
- Stroke: death as a direct consequence or complication of stroke
- Cardiovascular procedure
- Cardiovascular-related haemorrhage: non-stroke intracranial haemorrhage (subdural hematoma), non-procedural or non-traumatic vascular rupture (e.g. aortic aneurysm), or haemorrhage causing cardiac tamponade
- Death due to other cardiovascular causes: a cardiovascular death not included in the above categories but with a specific, known cause (e.g., pulmonary embolism or peripheral arterial disease)
Accepted time for evaluation is +/- 30 days
Measured: 12 months and 36 months post-randomization.
Cognitive decline
A significant cognitive decline, defined as a ≥2-point reduction in Montreal Cognitive Assessment (MoCA) scores at 36 months.
The participant's score on the full 12 item in-person MoCA (30 points) at the initial visit is compared to the scores on the telephone administrated Tele-MoCA (items from MoCA not requiring the use of a pencil and paper or visual stimulus, maximum of 22 points) after 12 and 36 months.
Accepted time for evaluation is +/- 30 days
Measured: After 12 months and a end of treatment at 36 months
Serious adverse event (SAE)
Information on SAEs will be reported by the investigators and recorded in the eCRF.
Measured: From enrollment to the end of treatment at 36 months
Baseline MRI risk markers, quantified using the ordinal simplified SVD-score (small vessel disease) score
Simple SVD defined as score: Microbleeds: 0 microbleeds = 0 point; ≥ 1 microbleed = 1 point White matter hyperintensities (Fazekas): Fazekas 0-1 = 0 point; Fazekas 2-3 = 1 point. Lacunes: 0-2 lacunes = 0 point; >2 lacunes = 1 point. Total SVD score (range): 0-3.
Measured: After 12 months and at the end of treatment at 36 months
Physical activity levels
Baseline physical activity levels are measured by the International Physical Activity Questionnaire (IPAQ).It yields a categorical score: low, moderate, or high level of physical activity. The follow-up assessment will be performed by staff from the enrolling site.
Accepted time for evaluation is +/- 30 days
Measured: At baseline
Modified Rankin Scale (mRS) score
The change in mRS score will be assessed to evaluate shifts in functional independence and disability over time. The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. The follow-up assessment at 12 and 36 months will be performed by staff from the enrolling site.
Accepted time for evaluation is +/- 30 days
Measured: From baseline to 12 months and to the end of treatment at 36 months
Clinical Frailty Scale (CFS) score
The change in CFS score will be assessed from baseline to 12 and 36 months to evaluate the progression of frailty and its impact on functional status and overall health over time. It ranges from 1 to 9, with 1 indicating "very fit" and 9 indicating "terminally ill." The follow-up assessments at 12 and 36 months will be performed by staff from the enrolling site Accepted time for evaluation is +/- 30 days
Measured: From baseline to 12 months and to the end of treatment at 36 months
Barthel Index (BI) for Activities of Daily Living (ADL)
The Barthel Index is a score that describes the degree of independence in relation to assistance from another person. It ranges from 0 to 100, with higher scores indicating greater independence. A score close to 100 reflects that the individual is self-sufficient, whereas lower scores indicate increasing dependence on others in daily activities. A score near 0 typically suggests that the individual is bedridden and requires help with all tasks.
The follow-up assessments at 12 and 36 months will be performed by staff from the enrolling site.
Accepted time for evaluation is +/- 30 days
Measured: From enrollment to 12 months and to the end of treatment at 36 months
Quality of life (EQ-5D)
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The follow-up assessments at 12 and 36 months will be performed by staff from the enrolling site.
Accepted time for evaluation is +/- 30 days
Measured: From enrollment to 12 months and to the end of treatment at 36 months
CBI subtype
The CBI subtype and infarct appearance will be described by the enrolling physician, who has been trained to identify these findings on MRI.
The baseline MRI will be visually graded by the investigators and the total SVD score calculated.
The DICOM (Digital Imaging and Communications in Medicine) file containing the MRI will be downloaded and uploaded to the electronic case report form (eCRF) at redcap.au.dk, for later assessment by an imaging core lab.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start26 Nov 2025
- Primary completion30 Sep 2031 (estimated)
- Study completion1 Jan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covert Brain InfarctionStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,652 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Bispebjerg Hospital, Herlev Hospital, Zealand University Hospital, Odense University Hospital, Aalborg University Hospital, Gødstrup Hospital, Oslo University Hospital, Universitätsklinikum Hamburg-Eppendorf, Insel Gruppe AG, University Hospital Bern, Lund University Hospital
- Responsible party
- Principal investigator, Rolf Blauenfeldt, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012629
- Sponsor's protocol ID
- 2025-521452-30-01
- Other IDs
- 2025-521452-30-01, 2025
- Acronym
- EURO-CBI
- Status last verified
- Nov 2025
- First submitted
- 1 Jun 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the baseline screening visit and 3 years outcome can be shared after de-identification, upon reasonable request and proposals should be directed at the principal study investigator. To gain access to these data, data requestors will need to sign a data processing agreement. Further, anonymized data will be available through public databases such as the Zenodo open data repository (CERN) or other equivalent databases after trial completion.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A EUROpean Pragmatic Multicenter Randomized Trial on Platelet Inhibition and/or Lipid Lowering Treatment in Covert Brain Infarction (CBI)
- ClinicalTrials.gov ID
- NCT07012629
- Acronym / sponsor ID
- EURO-CBI / 2025-521452-30-01
- Conditions
- Covert Brain Infarction
- Keywords
- CBI, Prevention, Asymptomatic brain infarction, Dementia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,652 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Bispebjerg Hospital, Herlev Hospital, Zealand University Hospital, Odense University Hospital, Aalborg University Hospital, Gødstrup Hospital, Oslo University Hospital, Universitätsklinikum Hamburg-Eppendorf, Insel Gruppe AG, University Hospital Bern, Lund University Hospital
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 30 Sep 2031 (estimated)
- Study completion
- 1 Jan 2040 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 factorial
| Arm | Type | Receives |
|---|---|---|
| Group A: Platelet inhibitor - no Statin ("APT alone") | Experimental | Drug: acetylsalicyclic acid (ASA), Drug: ClopidogrelAll 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. |
| Group B: Statins - no Platelet inhibitor ("Statin alone"). | Experimental | Drug: Rosuvastatin, Drug: AtorvastatinPatients will be treated with high-intensity statin therapy (Atorvastatin 40 mg once daily or Rosuvastatin 20 mg once daily) |
| Group C: Statins - Platelet inhibitor ("APT AND statin") | Experimental | Drug: acetylsalicyclic acid (ASA), Drug: Clopidogrel, Drug: Rosuvastatin, Drug: AtorvastatinBoth types of medication are initiated as described in group A and B |
| Group D: No Statins - no Platelet inhibitor (current standard treatment) | No intervention | –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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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 and/or prior lobar hemorrhage)
- 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, lower-extremity atherosclerotic arterial disease etc.)
- Co-existing progressive neurodegenerative disease including dementia or Parkinson's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetylsalicyclic acid (ASA)Also: AspirinDaily dose 75 mg to 100 mg p.o. | Drug | Group A: Platelet inhibitor - no Statin ("APT alone"), Group C: Statins - Platelet inhibitor ("APT AND statin") |
| ClopidogrelDaily dose 75 mg p.o. | Drug | Group A: Platelet inhibitor - no Statin ("APT alone"), Group C: Statins - Platelet inhibitor ("APT AND statin") |
| RosuvastatinDaily dose 20 mg p.o. (10 mg once daily for the first 4 weeks, then 20 mg once daily for the remainder of the study period if tolerated). If Rosuvastatin 20 mg is not tolerated, a dose reduction to 10 mg is allowed. | Drug | Group B: Statins - no Platelet inhibitor ("Statin alone")., Group C: Statins - Platelet inhibitor ("APT AND statin") |
| AtorvastatinDaily dose 40 mg p.o. If Atorvastatin 40 mg is not tolerated, a dose reduction to 20 mg is allowed. | Drug | Group B: Statins - no Platelet inhibitor ("Statin alone")., Group C: Statins - Platelet inhibitor ("APT AND statin") |
Primary outcome
Major Adverse Cardiac and Cerebral Events (MACCE) at 12 and 36 months
Time frame: 12 months and 36 months post-randomization.
MACCE are defined as the occurrence of any of the following events * All cause death: Death from any cause * Acute myocardial infarction: Admission with a discharge diagnosis of ST-elevation myocardial infarction (STEMI) and non-ST elevation myocardial infarction (NSTEMI) and * Stroke: AIS* or Intracerebral hemorrhage (non-traumatic) *Including Transient Ischemic Attack (TIA) with evidence of brain tissue infarction i.e. remission of symptoms within 24 hours but who have an acute ischemic lesion on diffusion weighted imaging MRI. All events qualifying for a MACCE event will be adjudicated by the Clinical event committee. Accepted timeframe for evaluation is +/- 30 days
Major and fatal bleeding at 12 and 36 months
Time frame: 12 months and 36 months post-randomization.
Major and fatal bleeding events are defined according to criteria established by the International Society on Thrombosis and Haemostasis (ISTH): * Fatal bleeding, and/or * Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome, and/or * Bleeding leading to a drop in hemoglobin of ≥20 g/L (1.24 mmol/L), or requiring transfusion of two or more units of whole blood or red cells. All qualifying events will be adjudicated by an independent Clinical Event Committee (CEC). The accepted time window for assessment is ±30 days.
11 secondary outcomes
All-cause dementia
Time frame: 12 months and 36 months post-randomization.
Cardiovascular-related mortality
Time frame: 12 months and 36 months post-randomization.
Cognitive decline
Time frame: After 12 months and a end of treatment at 36 months
Serious adverse event (SAE)
Time frame: From enrollment to the end of treatment at 36 months
Baseline MRI risk markers, quantified using the ordinal simplified SVD-score (small vessel disease) score
Time frame: After 12 months and at the end of treatment at 36 months
Physical activity levels
Time frame: At baseline
Modified Rankin Scale (mRS) score
Time frame: From baseline to 12 months and to the end of treatment at 36 months
Clinical Frailty Scale (CFS) score
Time frame: From baseline to 12 months and to the end of treatment at 36 months
Barthel Index (BI) for Activities of Daily Living (ADL)
Time frame: From enrollment to 12 months and to the end of treatment at 36 months
Quality of life (EQ-5D)
Time frame: From enrollment to 12 months and to the end of treatment at 36 months
CBI subtype
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data underlying the baseline screening visit and 3 years outcome can be shared after de-identification, upon reasonable request and proposals should be directed at the principal study investigator. To gain access to these data, data requestors will need to sign a data processing agreement. Further, anonymized data will be available through public databases such as the Zenodo open data repository (CERN) or other equivalent databases after trial completion.
Related trials for Covert Brain Infarction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acetylsalicyclic acid (ASA), Clopidogrel and Rosuvastatin in people with Covert Brain Infarction, run by Aarhus University Hospital at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Denmark, Germany, Norway, Sweden, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rolf Blauenfeldt (+4529318244, rolfblau@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac and Cerebral Events (MACCE) at 12 and 36 months (time frame: 12 months and 36 months post-randomization.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.