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Efficacy and safety analysis of PCSK9 inhibitors in patients with acute ischemic stroke caused by symptomatic intracranial atherosclerotic stenosis

Efficacy and safety analysis of PCSK9 inhibitors in patients with acute ischemic stroke caused by symptomatic intracranial atherosclerotic stenosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069104
Enrollment
Unknown
Registered
2023-03-07
Start date
2023-03-10
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic cerebrovascular disease

Interventions

Group A:PCSK9i + atorvastatin calcium 20mg/ rosuvastatin calcium 10mg
Group B:atorvastatin calcium 40mg/ rosuvastatin calcium 20mg

Sponsors

The Second Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age: 18-80 years old; 2) Patients with acute ischemic stroke; 3) NIHSS score: < 21 (light to medium); 4) The TOAST classification is large artery atherosclerosis; 5) The infarct area was symptomatic intracranial atherosclerosis (ICAS), which only involved one cerebral hemisphere, and the symptomatic ICAS occurred in the internal carotid artery system; 6) serum low-density lipoprotein cholesterol (ldl-c) =1.8mmol/L; 7) The NIHSS score is not affected in patients with first onset or previous cerebral infarction who have no residual sequelae such as limb paralysis, and the previous mRS score = 1. 8) Subjects or legal guardians agree to accept the drug treatment methods formulated in the study protocol, participate in the evaluation and complete the imaging and blood tests on time, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Intracranial artery stenosis after endovascular treatment or endarterectomy; 2) Extracranial artery stenosis (including carotid or vertebral artery) > 50%; 3) Patients have high risk factors for cardioembolism, including acute myocardial infarction, atrial fibrillation, valvular heart disease or severe heart failure; 4) The lesions were caused by non-atherosclerotic diseases, such as arterial dissection, shock, coagulopathy, vasculitis, antiphospholipid antibody syndrome, intracranial infection, myofiber dysplasia, moyamoya disease, CADASIL, etc. 5) Ischemic stroke caused by angiography or surgery; 6) Intracranial hemorrhage confirmed by head CT or MRI; 7) Contraindicated or allergic to ileumumab or gadolinium contrast; 8) subjects with major diseases include but are not limited to: severe renal impairment, such as serum creatinine > 265umol/L, severe kidney disease requiring hemodialysis or peritoneal dialysis; Or severe liver damage, such as active liver disease, AST or ALT more than 3 times the normal value, hyperbilirubinemia, cirrhosis, hepatic encephalopathy; Or severe congestive heart failure (NYHA grade 3 and 4) or a history of MI in the last 6 months; Or severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease (COPD) and pneumonectomy; Or patients with serious blood system diseases such as coagulopathy, systemic bleeding tendencies and thrombocytopenia; 9) Patients who are pregnant, breastfeeding or have the possibility or plan to become pregnant; 10) Participating in other clinical trials; 11) systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg, and oral antihypertensive drugs cannot control; 12) Unable to perform CT or MRI for any reason, or unable to cooperate with follow-up for clinical evaluation, laboratory or imaging evaluation (e.g., severe dementia or mental disorder, severe metabolic disease, pregnant or lactating women, life expectancy of less than 6 months due to advanced stage of any disease); 13) The researchers judged that they were not suitable to participate in the study.

Design outcomes

Primary

MeasureTime frame
LDL-C value;Internal carotid atherosclerotic plaque size;Degree of stenosis of internal carotid artery lumen;mRS score;

Secondary

MeasureTime frame
Inflammatory factor index;Clinical prognosis and safety events;

Countries

China

Contacts

Public Contactyongzhong lin

The Second Affiliated Hospital of Dalian Medical University?

Lin19671024@163.com17709873166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026