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EUROpean pragmatic multicenter randomized trial on platelet inhibition and/or lipid lowering treatment in Covert Brain Infarction (CBI)
EU CTIS ID: 2025-521452-30-01
What this study is testing
Primary efficacy objective: To evaluate whether antiplatelet and/or statins in addition to risk factor management will provide a net long-term benefit in reducing vascular events and death (Major Adverse Cardiac and Cerebral Events (MACCE)) at 3 years in patients with covert brain infarctions. Primary safety objective: To evaluate the cumulative risk of major and fatal bleeding at 36 months in patients with covert brain infarctions.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Deep/Lacunar infarct 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 Cortical infarct 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.
- Life expectancy > 12 months
- Predominantly independent in actives of daily living (mRS score ≤ 3)
- Age ≥ 50 years
You likely can't join if
- History of stroke/TIA
- Breast-feeding
- Patients with myopathy and/or elevated creatine kinase (CK) >5 × upper limit of normal (ULN)
- A history of significant liver disease and/or excessive alcohol intake and/or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal (excessive alcohol intake defined as a history of alcohol-related liver dysfunction, including clinical signs such as ascites, spider naevi, caput medusae, or other stigmata of chronic liver disease.)
- Patients treated with the hepatitis C antivirals glecaprevir/pibrentasvir
- Patients receiving a combination of sofosbuvir/velpatasvir/voxilaprevis
See the full eligibility criteria
- Deep/Lacunar infarct 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 Cortical infarct 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.
- Life expectancy > 12 months
- Predominantly independent in actives of daily living (mRS score ≤ 3)
- Age ≥ 50 years
- History of stroke/TIA
- Breast-feeding
- Patients with myopathy and/or elevated creatine kinase (CK) >5 × upper limit of normal (ULN)
- A history of significant liver disease and/or excessive alcohol intake and/or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal (excessive alcohol intake defined as a history of alcohol-related liver dysfunction, including clinical signs such as ascites, spider naevi, caput medusae, or other stigmata of chronic liver disease.)
- Patients treated with the hepatitis C antivirals glecaprevir/pibrentasvir
- Patients receiving a combination of sofosbuvir/velpatasvir/voxilaprevis
- Patients receiving concomitant ciclosporin
- Severe renal impairment (creatinine clearance <30 ml/min)
- Hypersensitivity to the active substance or to any of the excipients
- 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 of childbearing potential (WOCBP), defined as all women who have not undergone bilateral oophorectomy, hysterectomy, or medically confirmed ovarian failure, or who have not been postmenopausal for at least 12 consecutive months without an alternative medical cause, are excluded unless the following criteria are met: 1) A negative pregnancy test at baseline; and 2) Use of highly effective contraceptive measures throughout the study period.
- History of peptic ulcer disease or symptoms suggestive of active gastritis
The study team makes the final eligibility decision.
Where it's taking place
- 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. 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 EU CTIS; the study team decides eligibility.