The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile
- Sponsor
- Sun U. Kwon
- Study ID
- NCT06083961
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- PCSK9 Inhibitor
- Stroke, Acute Ischemic
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Alirocumab — DRUGInitial alirocumab, single dose of 300mg, subcutaneous injection
Study Details
The goal of this clinical trial is to test the effect of proprotein convertase subtilisin/kexin type 9 (PCSK9 inhibitors) in acute ischemic stroke patients associated with atherosclerosis by investigating 1. the change in lipid profile compared to baseline results 2. the effects on prognosis of stroke The participants will be given PCSK9 inhibitor right after confirmation of acute ischemic stroke, and the investigators will compare the results to the control group, whom are acute ischemic stroke patients treated with conventional lipid lowering therapy, statin and/or ezetimibe.
Key Dates
- Start date
- Oct 15, 2023
- Status verified
- Oct 2023
- Primary completion
- Oct 15, 2026
- Completion
- Nov 15, 2026
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: AlirocumabThe treatment group patients will receive an additional PCSK9 inhibitor (alirocumab 300mg once) at emergency departement in addition to statin therapy, which is conventional medication given for acute ischemic stroke.
- No Intervention: Standard of careThe control group patients will receive standard and conventional acute ischemic stroke treatment, which includes statin therapy.
Primary Outcome Measure
LDL change rate [ Time Frame: LDL level at initial state (before injection, day-0), day-1, day-3, before discharge (normally day-5 to day-7), and day-30 (Outpatient department follow up). ]