NCT05001984

Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis

Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis - a Prospective, Randomized, Open-label, Blinded End-point Study with High-resolution MR Vessel Wall Imaging

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Intracranial Atherosclerosis
• Acute Ischemic Stroke
• ICAS - Intracranial Atherosclerosis

Interventions

Type	Name	Description
DRUG	Alirocumab	Alirocumab 75mg subcutaneously every 2 weeks for a total of 26 weeks.

Timeline

• Start date: 2021-08-01
• Primary completion: 2025-04-15
• Completion: 2025-04-15
• First posted: 2021-08-12
• Last updated: 2025-03-26

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study