A multicenter prospective randomized-controlled interventional study to evaluate the effect of high dose rosuvastatin versus high dose rosuvastatin and ezetimibe in acute ischemic stroke patients
Not Applicable
Recruiting
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0007204
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 330
Inclusion Criteria
1. Those with primary hypercholesterolemia among those whose lesions were confirmed by brain CT or MRI within 48 hours of the onset of ischemic stroke
2. Adults 19 years of age or older
3. Patients who agreed to participate in this study
Exclusion Criteria
1. Patients scheduled for carotid endarterectomy or stenting, cerebral artery stenting, coronary angioplasty and stenting, or coronary artery bypass surgery within 3 months
2. Patients with malignant tumors that have not been cured
3. Patients who have participated in other drug clinical trials within the last 30 days
4. Patients expected to experience side effects when taking rosuvastatin and ezetimibe
5. Patients who did not consent to participate in this study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute value of LDL-C reduction
- Secondary Outcome Measures
Name Time Method Percentage of reaching target LDL-C levels (LDL < 70 mg/dL or 50% or more decrease from baseline); Changes in total cholesterol, HDL-C, and TG levels at 3 months compared to randomization;Clinical event – ??major cardiovascular adverse event (MACE; relapse of stroke, cardiovascular death, other death, occurrence of coronary artery disease, occurrence of myocardial infarction requiring PCI); Clinical Scale – NIHSS score, mRS score MMSE, GDS, GDpS, HADS;Safety endpoints – newly diagnosed diabetes mellitus, muscle symptoms, liver enzyme levels, intracranial hemorrhage; Imaging indicators – changes in vascular wall thickness, plaque volume, TCD parameters, etc. on carotid ultrasound , cerebral vascular activation (enhancement or not, enhancement pattern, enhancement volume)];Changes in insulin resistance (using fasting blood insulin and fasting glucose)