Clinical study of precise anti-plate and enhanced lipid-lowering in acute disabling TIA/ mild stroke

Phase 1

• Conditions: Acute disabling TIA/ minor stroke

• Registration Number: ChiCTR2400088950
• Lead Sponsor: The Affiliated Xuzhou Municipal Hospital of Xuzhou Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Patients aged 30-80 years (including boundary values) (2) who met one of the following conditions: (1) patients with TIA within 14 days of onset (ABCD2 baseline score =4) (2) patients with non-severe ischemic stroke within 14 days of onset (modified Rankin score =3); (3) Symptomatic intracranial artery stenosis: internal carotid artery C6-7 segment, middle cerebral artery M1 segment, vertebral artery or basilar artery, narrow 50-99% narrow, diagnosed by MRA, CTA, or DSA; (4) Atherosclerosis was identified as the cause of intracranial artery stenosis by high-resolution magnetic resonance imaging.

Exclusion Criteria

(1) The presence of upstream concatenated extracranial vessel stenosis (=50%) adjacent to the target intracranial stenosis vessel, or the identification of symptomatic vessels. (2) Non-atherosclerotic intracranial arterial stenosis, including arterial dissection; Moyamoya disease; Systemic vasculitis and primary CNS vasculitis; Varicella zoster or other viral vascular diseases; Neurosyphilis and other intracranial infections; Radiation vascular disease; Fibromuscular dysplasia; Sickle cell disease; Neurofibromatosis; Reversible vasoconstrictor syndrome; Postpartum vascular disease; Suspected blood<br>Tube spasm; Reopening after a suspected embolism. (3) Received extracranial/intracranial intravascular intervention within 30 days prior to enrollment or planned intravascular intervention within half a year (pack Including intracranial stents,endarterectomy, and thrombectomy). (4) Patients with any intracranial hemorrhage (parenchyma, subarachnoid space, subdural, or epidural) in the 90 days prior to enrollment. (5) Patients with intracranial tumors, brain aneurysms or arteriovenous malformations before enrollment. (6) The presence of any of the following clear sources of cardiac embolism: mitral stenosis, mechanical valves, endocarditis, intracardiac clots or neoplasia, myocardial infarction within three months, dilated cardiomyopathy, chronic or paroxysmal atrial fibrillation, or ejection fraction less than 30%. (7) AST and/or ALT> 3 times the upper limit; Creatinine clearance < 0.6 mL/s and/or serum creatinine >265 µmol/L (>3.0 mg/dL); CK > 5 times the upper limit at screening. (8) Retinal hemorrhage; Active bleeding tendency or coagulation dysfunction; Active peptic ulcer disease, major systemic bleeding within the last 30 days, active bleeding tendency, platelet count < 125,000, hematopoietic volume < 30, hemoglobin < 10 g/dL, corrected International normalized ratio (INR) > 1.5, bleeding time over the upper limit at screening 1 minute, Or increased risk of bleeding due to heparin-related thrombocytopenia. (9) Surgery within 30 days prior to enrollment or within 6 months after enrollment, including heart and open femur, aorta, or carotid artery surgery. (10) Severe neurological deficits that make the patient unable to live independently; Has a diagnosis of dementia or mental illness that prevents the patient from completing the follow-up plan; Or other diseases that may limit survival to less than three years. (11) Pregnancy, lactation or planned pregnancy. (12) Use of PCSK9 inhibitors or cholesterol ester transporter inhibitors in the 24 weeks prior to enrollment. (13) Patients with systemic immune diseases: systemic sclerosis, systemic lupus erythematosus, Sjogren's syndrome, Behset's disease, mixed connective tissue disease, IGG4-related diseases. Uncontrolled hypertension during the screening period: defined as sitting systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg. (15) New York Heart Association (NYHA) Grade III or IV heart function, or a known left ventricular ejection fraction <30%. (16) There are relative/absolute contraindication signs for MRI imaging (such as metal in the body, claustrophobia, contrast agent allergy, severe kidney damage, epilepsy, hypotension, asthma and other allergic respiratory diseases and people with allergic tendencies). (17) Previous allergy or intolerance to the investigational drugs (including statins and PCSK9 inhibitors, etc.). (18) Is participating in another study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intracranial arterial plaque load;

Secondary Outcome Measures

Name	Time	Method
early recurrent stroke(ERS);low-density lipoprotein cholesterol(LDL-C);Total Cholesterol(TC) Triglycerides(TG) High-Density Lipoprotein Cholesterol (HDL-C) Lipoprotein(a) Apolipoprotein A1 (ApoA1) Apolipoprotein B (ApoB);modified Rankin Scale (mRS);National Institutes of Health Stroke Scale (NIHSS);