PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke

Prior treatment

• Previous stent implantation in the culprit vessel or planned stent implantation in the culprit vessel within 3 months after enrollment.
• Any intracranial hemorrhage within 3 months before enrollment.
• Treatment with a PCSK9 monoclonal antibody inhibitor within 1 month before enrollment or with a PCSK9-targeting small interfering RNA therapy within 6 months before enrollment.

Other illness

• Intracranial arterial stenosis attributable to a nonatherosclerotic cause, such as arterial dissection, moyamoya disease, or systemic vasculitis.
• Any definite source of cardioembolism, such as atrial fibrillation, a mechanical prosthetic heart valve, left ventricular thrombus, or patent foramen ovale.
• Clinical and imaging findings suggesting that the index ischemic event is primarily attributable to cerebral small vessel disease.
• Pre-stroke disability, defined as a modified Rankin Scale score of 2 or higher before the index ischemic event.
• Extensive cerebral infarction on CT or MRI, such as an Alberta Stroke Program Early CT Score (ASPECTS) below 6 or an infarct volume of 70 mL or greater.
• Severe active bleeding tendency or coagulation disorder.
• Severe cardiac, hepatic, renal, or other major organ dysfunction.
• A definite contraindication to statin therapy or a history of statin intolerance.

Other

• An intracranial tumor; or a cerebral aneurysm or arteriovenous malformation judged to require interventional treatment.
• Pregnant or breastfeeding, or planning to become pregnant during the study.
• Current participation in another clinical trial.

• Age 30 to 80 years, inclusive.
• Acute ischemic stroke with symptom onset within 72 hours before screening, diagnosed on the basis of neurological deficits and CT or MRI findings.
• National Institutes of Health Stroke Scale (NIHSS) score of 4 to 25 at hospital admission.
• CTA, DSA, or MRA evidence that the culprit intracranial artery has atherosclerotic stenosis of 50% to 99%.