Can a Cholesterol-Lowering shot reverse brain artery blockages?
NCT ID NCT06902740
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding a PCSK9 inhibitor (Recaticimab) to standard statin therapy can reverse plaque buildup in brain arteries of people with asymptomatic intracranial atherosclerosis. About 300 participants will receive either the drug combo or statins alone for 24 weeks. The main goal is to see if plaque burden decreases on MRI scans, which could lower future stroke risk.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Recaticimab (a PCSK9 inhibitor) combined with statin (rosuvastatin or atorvastatin)
- What this could lead to
- If successful, this could show that adding a PCSK9 inhibitor to statins reverses artery plaque in the brain, potentially reducing stroke risk.
- What could go wrong
- This is a Phase 4 trial with 300 participants, but it is open-label (not blinded for patients) and uses imaging endpoints rather than clinical outcomes like stroke reduction. Results may not translate to fewer strokes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 and ≤80, male or female; 2. Asymptomatic intracranial artery stenosis (50%-99%) in the internal carotid artery (C6-7 segments), middle cerebral artery (M1 segment), vertebral artery (V4 segment), or basilar artery, confirmed by angiography (MRA, CTA, or DSA); 3. Atherosclerosis identified as the cause of intracranial artery stenosis by high-resolution magnetic resonance imaging; 4. No previous ischemic cerebrovascular events (including ischemic stroke or transient ischemic attack). 5. Baseline low-density lipoprotein cholesterol ≥ 1.8 mmol/L; 6. Informed consent signed. Exclusion Criteria: 1. Non-atherosclerotic intracranial artery stenosis, including arterial dissection; moya moya disease; systemic vasculitis and primary central nervous system vasculitis; varicella-zoster vasculopathy or other viral vasculopathy; neurosyphilis and other intracranial infections, radiation vasculopathy; fibromuscular dysplasia, sickle cell disease, neurofibromatosis; reversible cerebral vasoconstriction syndrome; postpartum vasculopathy; suspected vasospasm, suspected reperfusion after vessel occlusion. 2. Upstream tandem extracranial vessel stenosis (≥50%) adjacent to the target intracranial stenotic vessel. 3. Previous treatment of target intracranial lesion with endovascular intervention or plan to perform endovascular intervention within 6 months, including intracranial stenting, endovascular angioplasty, and thrombectomy. 4. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, extradural, intraventricular) within 90 days prior to enrollment. 5. Presence of intracranial tumors. 6. Presence of cerebral aneurysms or arteriovenous malformations with indications for interventional therapy. 7. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 6 months after enrollment. 8. Presence of any of the following unequivocal cardiac sources of embolism: mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, chronic or paroxysmal atrial fibrillation. 9. New York Heart Association (NYHA) class III or IV, or known left ventricular ejection fraction \< 30%. 10. Severe liver dysfunction or severe kidney dysfunction: AST and/or ALT \> 3 times the ULN; creatinine clearance \< 0.6 mL/s and/or serum creatinine \> 265 μmol/L (\>3.0 mg/dL); CK \>5 times the ULN at screening. 11. Active bleeding diathesis or coagulopathy (e.g., active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets count \< 125,000 / uL, hematocrit \< 30%, Hgb \< 10 g/dl, international normalized ratio \>1.5, bleeding time \> 1 minute beyond normal value upper limit). 12. Presence of systemic autoimmune diseases: systemic sclerosis, systemic lupus erythematosus, Sjögren's syndrome, Behçet's disease, mixed connective tissue disease, IgG4-related disease. 13. Dementia or psychiatric problem that hinder their ability to consistently adhere to an outpatient program. Co-morbid conditions that may limit the life expectancy to less than 3 years. 14. Relative/absolute contraindications to magnetic resonance imaging (MRI) (such as presence of internal metallic objects, claustrophobia, contrast agent allergy, severe renal impairment, epilepsy, hypotension, asthma, and other hypersensitivity respiratory diseases). 15. Uncontrolled hypertension during the screening period, defined as seated systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg. 16. Prior use of PCSK9 inhibitor before this recruitment. 17. Known intolerance or allergy to statin. 18. Pregnancy, lactation, or planning pregnancy. 19. Currently participating in another study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
19 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baotou Central Hospital
NOT_YET_RECRUITINGBaotou, Inner Mongolia, 014000, China
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Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
NOT_YET_RECRUITINGCangzhou, Hebei, China
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Chinese PLA General Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100853, China
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Chongqing General Hospital
NOT_YET_RECRUITINGChongqing, China
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First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITINGHarbin, Heilongjiang, China
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Hebei Provincial People's Hospital
RECRUITINGShijiazhuang, Hebei, 050051, China
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Huashan Hospital, Fudan University
NOT_YET_RECRUITINGShanghai, China
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Jining First People's Hospital
NOT_YET_RECRUITINGJining, Shandong, 272000, China
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Liaocheng People's Hospital
NOT_YET_RECRUITINGLiaocheng, Shandong, 252000, China
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Nanjing First Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210000, China
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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITINGBeijing, Beijing Municipality, 100730, China
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Peking University Third Hospital Qinhuangdao Hospital
NOT_YET_RECRUITINGQinhuangdao, Hebei, China
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Taihe Hospital
NOT_YET_RECRUITINGShiyan, Hubei, 442000, China
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Tangshan Worker's Hospital
NOT_YET_RECRUITINGTangshan, Hebei, 063000, China
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The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITINGQingdao, Shandong, China
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The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital
NOT_YET_RECRUITINGMeizhou, Guangdong, China
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The first affiliated hospital of zhengzhou university
NOT_YET_RECRUITINGZhengzhou, Henan, China
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Weifang People's Hospital
NOT_YET_RECRUITINGWeifang, Shandong, 261000, China
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Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITINGWuhan, Hubei, China
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Other studies related to the condition(s) this trial covers.
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- Hunting the hidden warning signs of heart attacks and strokes
- Can an unapproved device change how we manage this condition?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better
- Can stronger cholesterol drugs silence the threat of stroke?
- Cholesterol control may cut stroke risk in brain artery disease