Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis (NCT05001984) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis
Taiwan60 participantsStarted 2021-08-01
Plain-language summary
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with alirocumab results in greater change from baseline in intracranial atherosclerotic plaque at week 26 than control in adults with acute ischemic stroke from intracranial atherosclerosis taking lipid lowering therapy.
Who can participate
Age range20 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) score of 1-15
* Ischemic lesions on diffuse-weighted imaging located in the territory of symptomatic intracranial atherosclerosis (ICAS).
* Symptomatic ICAS (above 30%) at the M1 or M2 of the middle cerebral artery, basilar artery or at the intracranial portion of the internal carotid artery or vertebral artery.
* Serum LDL-C ≥70 mg/dL for subjects on lipid-lowering therapies (such as a statin and/or ezetimibe) or LDL-C ≥100 mg/dL for subjects without lipid-lowering therapies.
* Ability to randomize within 7 days of time last known free of new ischemic symptoms.
* Ability to receive alirocumab or statin treatment within 7 days of stroke onset.
* Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy.
* Pre-stroke modified Rankin Scale (mRS)≦2
Exclusion Criteria:
* Age \<20 years.
* Judged by clinical physician.
* After endovascular intervention or endarterectomy for the symptomatic ICAS.
* Patients with more than 50% stenosis of extra-cranial arteries the relevant arteries on magnetic resonance angiography (MRA), including extra-cranial carotid artery or vertebral arteries.
* Patients with high risk of cardioembolic source, such as atrial fibrillation, acute myocardial infarction, severe heart failure or valvular heart disease.
* Other determined stroke e…
What they're measuring
1
The changes of intracranial atherosclerotic plaque: stenosis degree
Timeframe: 26 weeks
2
The changes of intracranial atherosclerotic plaque: percent atheroma volume
Timeframe: 26 weeks
3
The changes of intracranial atherosclerotic plaque: enhancement volume