Metabolic syndrome with ischemic stroke
Conditions
Interventions
control group:Ezetimibe 10mg combined with Atorvastatin 20mg, once daily.
Experimental Group:Hybutimibe 10mg combined with Atorvastatin 20mg, once daily. Ezetimibe 10mg combined with Atorvastatin 20mg, once daily.
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years old; gender is not limited; 2. Diagnosed with metabolic syndrome complicated by ischemic stroke; 3. Meeting at least three of the diagnostic criteria for metabolic syndrome: abdominal obesity (waist circumference >=90 cm for males, >=85 cm for females), hyperglycemia, hypertension, fasting triglycerides (TG) >=1.70 mmol/L, fasting high-density lipoprotein cholesterol (HDL-C) =2.6mmol/L; 6. Willing to take effective contraceptive measures during the trial period and for 28 days after the last administration of medication; 7. Able to understand and comply with the research procedures and methods, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of allergy to hybutimibe, ezetimibe, or statin; 2. Use of lipid-lowering monoclonal antibodies within 3 months prior to enrollment; 3. Women who are pregnant or planning to become pregnant; 4. Any clinically severe endocrine diseases that affect lipids or lipoproteins, such as thyroid dysfunction, nephrotic syndrome; 5. Patients with renal insufficiency (eGFR 114µmol/L for males; 6. Abnormal liver function (AST or ALT levels more than three times the upper limit of normal, or total bilirubin >1.5×ULN;Creatine kinase greater than three times the upper limit of normal or evidence of serologically confirmed infectious hepatitis;); 7. Individuals who cannot adhere to medication or regular follow-up; 8. Any other conditions deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline to week 12;Incidence of major adverse cardiovascular events (MACE) within 12 weeks;Recurrence rate of ischemic stroke within 12 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse neurological outcomes (mRS 2-6) within 90 days;Safety monitoring during the treatment period;Percentage changes from baseline in total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), serum creatinine (Cr), creatinine clearance (CrCl), and glomerular filtrat; | — |
Countries
China
Contacts
Public ContactLijie Ren
Shenzhen Second People's Hospital
Outcome results
None listed