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:
2025-12-25 @ 4:22 AM
Ignite Modification Date:
2025-12-25 @ 4:22 AM
NCT ID:
NCT06696820
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years.
2. Acute ischemic stroke diagnosed by CT or MRI of the head.
3. Symptom onset to randomization within 48 hours, including wake-up strokes or strokes without a witnessed onset. The time of symptom onset is defined as the "last known normal time."
4. NIHSS score ≤ 20.
5. mRS score of 0-1 prior to the current stroke.
6. Moderate or severe intracranial stenosis or occlusion (≥50%) confirmed by CTA, MRA, or DSA, involving the responsible intracranial arteries: intradural internal carotid artery, M1-2 segments of the middle cerebral artery, A1 segment of the anterior cerebral artery, V4 segment of the vertebral artery, basilar artery, or P1 segment of the posterior cerebral artery.
7. The participant or legal representative has signed the informed consent form.
Exclusion Criteria:
1. Cardiogenic embolism (e.g., atrial fibrillation, cardiac valvular disease, etc.).
2. Symptomatic intracranial stenosis or occlusion due to arteritis, arterial dissection, moyamoya disease, or other similar conditions.
3. Patients who have received intravenous thrombolysis or mechanical thrombectomy.
4. Use of PCSK9 inhibitors within the 1 month prior to the onset of the stroke.
5. Allergy to statins or PCSK9 inhibitors.
6. Active liver disease, including unexplained persistent elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST).
7. Known severe renal impairment (creatinine clearance \<30 mL/min).
8. Myopathy.
9. Concurrent use of cyclosporine.
10. Known pregnancy or breastfeeding, or a positive pregnancy test prior to randomization.
11. Life expectancy \<3 months (e.g., due to severe cardiopulmonary disease, renal failure, malignancy, or other terminal conditions).
12. Participation in other interventional clinical trials that may impact outcome assessments.
13. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation or poses significant risks to the patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06696820
Study Brief:
Protocol Section:
NCT06696820