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The early administration of PCSK9 inhibitors in patients with acute ischemic stroke and its impact on the prognosis of stroke and changes in lipid profiles

Not Applicable
Conditions
Diseases of the circulatory system
Registration Number
KCT0009238
Lead Sponsor
Asan Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
200
Inclusion Criteria

Non-cardioembolic Stroke
Acute Ischemic stroke within 7 days of symptom onset (confirmed by CT or MRI)
Age 19 and above
Significant stenosis associated with atherosclerosis in major intracranial / extracranial vessels.
National Institutes of Health Stroke Scale(NIHSS) score of 15 or less at admission
Patients with the capacity to consent for participation in the clinical trial.

Exclusion Criteria

Presence of high-risk factors for cardioembolism
Risk of ischemic stroke due to thrombosis from other causes
Patients with hemorrhagic stroke, brain tumors, or brain abscesses
Patients unable to take statins or PCSK9 inhibitors
Pre-stroke mRS score of 3 or higher
Severe liver failure (liver enzyme > 3 times the upper normal limit) or renal failure (serum Creatinine > 2mg/dL or estimated glomerular filtration rate < 30 mL/min/1.73m2)
Anemia (hemoglobin < 8mg/dL) or thrombocytopenia (platelet count < 100K)
Uncontrolled diabetes not managed by medication or insulin
Pregnant or breastfeeding patients
Patients already receiving PCSK-9 inhibitors
Patients deemed inappropriate for participation in the clinical trial by the investigator for other reasons.

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The extent of LDL-C reduction after alirocumab administration compared to the non-administration group;Comparison of the LDL-C Achievement Rates after alirocumab administration (? Below 70mg/dL, ? Below 55mg/dL, ? 50% reduction from baseline)
Secondary Outcome Measures
NameTimeMethod
Changes in the levels of triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, apolipoprotein, and lipoprotein(a) measured at admission and outpatient visit;The mRS and NIHSS scores measured at discharge, and the 3-month mRS scores;The difference in mRS and NIHSS scores between the groups, measured at admission, and at discharge.;Early neurological deterioration during admission;Hemorrhagic transformation or expansion of infarction at follow up MRI;C reactive protein and erythrocyte sedimentation rate during admission;Cardiovascular / Cerebrovascular events during the follow up period;Changes in HbA1c, liver function parameters, and muscleenzymes during the follow-up period
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