Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07341958
Eligibility Criteria:
Inclusion Criteria:
1. Age between 35 and 80 years, regardless of gender.
2. For patients with prior lipid-lowering treatment: screening LDL-C ≥1.8 mmol/L; for treatment-naïve patients: screening LDL-C ≥2.6 mmol/L.
3. Lp(a) ≥50 mg/dL.
4. Onset of symptoms within 3 to 7 days.
5. Diagnosis of ischemic stroke (NIHSS score ≤20) or high-risk TIA with ABCD² score ≥4; and meeting at least one of the following imaging criteria:
(1) Large-artery atherosclerosis (LAA) subtype per TOAST classification: vascular imaging confirms ≥50% atherosclerotic stenosis of the intracranial or extracranial culprit artery.
(2) Head CT or MRI demonstrates acute multiple infarcts, with etiology consistent with large-artery atherosclerosis (including nonstenotic vulnerable plaques).
6.The patient or their legally authorized representative has provided written informed consent.
Exclusion Criteria:
1. Patients who have undergone or are scheduled to undergo thrombolysis or thrombectomy therapy.
2. Definite cardiogenic ischemic cerebrovascular disease (e.g., accompanied by atrial fibrillation, prosthetic heart valves, atrial myxoma, infective endocarditis, etc.).
3. Other clearly identified etiologies of ischemic cerebrovascular disease (e.g., aortic dissection, cervical/cerebral arterial dissection, vasculitis, vascular malformations, moyamoya disease/syndrome, fibromuscular dysplasia, etc.).
4. Non-vascular intracranial diseases (e.g., intracranial tumors, multiple sclerosis, etc.).
5. Imaging findings indicating that the current cerebral infarction area exceeds 1/2 of a single brain lobe.
6. Imaging findings indicating hemorrhagic transformation of the current cerebral infarction.
7. Pre-stroke mRS score \> 2.
8. Patients with known allergies to Tafolecimab or other contraindications for its use.
9. Use of immunosuppressive drugs, antifungal drugs, or fibrates (which affect statin metabolism) within 14 days prior to randomization.
10. Creatine kinase levels exceeding 5 times the upper limit of normal after the onset of the event.
11. Severe hepatic or renal insufficiency prior to randomization (Note: Severe hepatic insufficiency is defined as ALT \>2×ULN or AST \>2×ULN; severe renal insufficiency is defined as serum creatinine \>1.5×ULN or GFR \<40 ml/min/1.73m²).
12. History of intracranial hemorrhage (e.g., ICH, SAH).
13. History of intracranial or extracranial vascular angioplasty.
14. History of gastrointestinal bleeding or major surgery within 90 days prior to enrollment.
15. Planned surgical or interventional procedures within the next 90 days that may necessitate discontinuation of the investigational drug.
16. Suffering from severe organic diseases with an expected survival time of less than 1 year.
17. Pregnant women, or women of childbearing potential who are not using effective contraception and lack documented pregnancy test results.
18. Currently participating in other investigational drug or device trials.
19. Inability to cooperate with follow-up due to geographic, social, or other reasons (e.g., alcohol abuse, substance abuse, dementia, severe psychiatric disorders, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT07341958
Study Brief:
Protocol Section:
NCT07341958