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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0007204

Enrollment

330

Registered

2022-04-18

Start date

2022-09-01

Completion date

Unknown

Last updated

2023-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Multicenter, randomized controlled trial to compare the efficacy and safety of the test group (high-dose rosuvastatin and ezetimibe combined administration group) and control group (high-dose r

It is an open-label, investigator-led clinical trial. In this clinical trial, treatment is performed according to the general treatment procedure for patients who have recently had an ischemic strok

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Absolute value of LDL-C reduction	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Korea, Republic of

Contacts

Public ContactBang-Hoon Cho

Korea University Anam Hospital

fevernakchal@naver.com+82-2-920-0000

Outcome results