A Phase 2 interventional study of Alirocumab in Intracranial Atherosclerosis, Acute Ischemic Stroke and ICAS - Intracranial Atherosclerosis, sponsored by Chang Gung Memorial Hospital. Active, not recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Chang Gung Memorial Hospital · Phase 2, Interventional, and Treatment
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.
In this trial, we will conduct a prospective, randomized, open-label, blinded end-point study using high-resolution MRI in patients with acute ischemic stroke from intracranial atherosclerosis to evaluate the efficacy and safety of alirocumab. We hypothesis that additional alirocumab treatment on a background of statin therapy could result in greater stabilization of intracranial plaque and regression of arterial stenosis.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In addition to high-intensity statin and antiplatelet treatment, patients will receive treatment of alirocumab 75mg subcutaneously every 2 weeks for a total of 26 weeks
Drug: Alirocumab
Patient will have high-intensity statin and antiplatelet treatment.
Alirocumab 75mg subcutaneously every 2 weeks for a total of 26 weeks.
Also known as: Praluent
The changes of intracranial atherosclerotic plaque: stenosis degree
The changes of intracranial atherosclerotic plaque in vessel-wall MRI before and after 6-month treatment, measured as stenosis degree. The degree of stenosis was calculated as: (1-lumen area of stenotic lesion/reference lumen area)×100%.
Time frame: 26 weeks
The changes of intracranial atherosclerotic plaque: percent atheroma volume
The changes of intracranial atherosclerotic plaque in vessel-wall MRI before and after 6-month treatment, measured as percent atheroma volume (PAV). The PAV was calculated using the following equation: PAV = Σ(EEM area - Lumen area) / ΣEEM area × 100, where EEM area is the cross-sectional area of the external elastic membrane and Lumen area is the cross-sectional area of the lumen.
Time frame: 26 weeks
The changes of intracranial atherosclerotic plaque: enhancement volume
The changes of intracranial atherosclerotic plaque in vessel-wall MRI before and after 6-month treatment, measured as enhancement volume. The enhancement volume was measured as post-contrast plaque enhancement for intracranial arteries and intraplaque hemorrhage.
Time frame: 26 weeks
Percentage of patients with major cardiovascular events
Defined as the composite of cardiovascular death, myocardial infarction, transient ischemic attack, ischemic stroke and hemorrhagic stroke.
Time frame: 26 weeks
Percentage of patients with myocardial infarction
patients with myocardial infarction
Time frame: 26 weeks
Percentage of patients with cardiovascular death
patients with cardiovascular death
Time frame: 26 weeks
Percentage of patients with stroke
Include transient ischemic attack, ischemic and hemorrhagic stroke
Time frame: 26 weeks
Percentage of patients with ischemic stroke or transient ischemic attack.
Percentage of patients with ischemic stroke or transient ischemic attack.
Time frame: 26 weeks
Percentage of patients with new ischemic lesions
Defined as new ischemic lesions in the territory of ICAS between 2 MRIs
Time frame: 26 weeks
Percentage of patients with favorable functional recovery
Defined as a mRS ≦2 mRS. The Modified Rankin Scale (mRS) runs from 0-6, running from perfect health without symptoms(score 0) to death(score 6).
Time frame: 3 months
Changes in serum biomarkers
Include liver function tests, HbA1c and lipid profiles.
Time frame: 26 weeks
Plan to share: No
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital