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New treatment option for Intracranial Atherosclerosis
Official title PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis
ClinicalTrials.gov ID: NCT06902740
What this study is testing
What is Recaticimab and Statin?
Recaticimab and Statin is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for intracranial atherosclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial designed to evaluate the efficacy and safety of PCSK9 inhibitor combined with statin therapy compared to statin monotherapy in reversing asymptomatic intracranial atherosclerosis, assessed using high-resolution magnetic resonance imaging of the intracranial vessel walls.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age ≥18 and ≤80, male or female;
- Asymptomatic intracranial artery stenosis (50%-99%) in the internal carotid artery (C6-7 segments), middle cerebral artery (M1 segment), vertebral...
- Atherosclerosis identified as the cause of intracranial artery stenosis by high-resolution magnetic resonance imaging;
- No previous ischemic cerebrovascular events (including ischemic stroke or transient ischemic attack).
- Baseline low-density lipoprotein cholesterol ≥ 1.8 mmol/L;
You likely can't join if
- Non-atherosclerotic intracranial artery stenosis, including arterial dissection; moya moya disease; systemic vasculitis and primary central nervous...
- Upstream tandem extracranial vessel stenosis (≥50%) adjacent to the target intracranial stenotic vessel.
- Previous treatment of target intracranial lesion with endovascular intervention or plan to perform endovascular intervention within 6 months...
- Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, extradural, intraventricular) within 90 days prior to enrollment.
- Presence of intracranial tumors.
- Presence of cerebral aneurysms or arteriovenous malformations with indications for treatment therapy.
See the full eligibility criteria
- Age ≥18 and ≤80, male or female;
- 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...
- Atherosclerosis identified as the cause of intracranial artery stenosis by high-resolution magnetic resonance imaging;
- No previous ischemic cerebrovascular events (including ischemic stroke or transient ischemic attack).
- Baseline low-density lipoprotein cholesterol ≥ 1.8 mmol/L;
- Informed consent signed.
- 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...
- Upstream tandem extracranial vessel stenosis (≥50%) adjacent to the target intracranial stenotic vessel.
- 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.
- Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, extradural, intraventricular) within 90 days prior to enrollment.
- Presence of intracranial tumors.
- Presence of cerebral aneurysms or arteriovenous malformations with indications for treatment therapy.
- Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 6 months after enrollment.
- 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...
- New York Heart Association (NYHA) class III or IV, or known left ventricular ejection fraction \< 30%.
- Severe liver dysfunction or severe kidney dysfunction: AST and/or ALT \> 3 times the ULN; creatinine clearance \ 265 μmol/L (\>3.0 mg/dL); CK \>5 times the ULN at screening.
- Active bleeding diathesis or coagulopathy (e.g., active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets count \ 1.5, bleeding time \> 1 minute beyond normal value...
- Presence of systemic autoimmune diseases: systemic sclerosis, systemic lupus erythematosus, Sjögren's syndrome, Behçet's disease, mixed connective tissue disease, IgG4-related disease.
- 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.
- 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...
- Uncontrolled hypertension during the screening period, defined as seated systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg.
- Prior use of PCSK9 inhibitor before this recruitment.
- Known intolerance or allergy to statin.
- Pregnancy, lactation, or planning pregnancy.
- Currently participating in another study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Meizhou, Guangdong, China
- Cangzhou, Hebei, China
- Qinhuangdao, Hebei, China
- Shijiazhuang, Hebei, China
- Tangshan, Hebei, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Shiyan, Hubei, China
- Wuhan, Hubei, China
- Baotou, Inner Mongolia, China
- Nanjing, Jiangsu, China
- Jining, Shandong, China
- Liaocheng, Shandong, China
- Qingdao, Shandong, China
- Weifang, Shandong, China
- Chongqing, China
- Shanghai, China
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 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Meizhou, Guangdong, China; Cangzhou, Hebei, China; Qinhuangdao, Hebei, China; Shijiazhuang, Hebei, China; Tangshan, Hebei, China and 12 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.