Effect on the vascular endothelium function of aggressive lipid control treatment with rosuvastatin -evaluation of a vascular endothelium function by Endo-PAT 2000

Not Applicable

• Conditions: The patients with hyper-LDL-cholesterolemia and stable coronary artery disease

• Registration Number: JPRN-UMIN000010040
• Lead Sponsor: Division of Cardiology, Department of Internal Medicine, Nihon University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients within 72 hr after the incidence of acute myocardial infarction. 2) Patients to be required the revascularization within 48 hours. 3) Familial hypercholesterolemia or secondary hypercholesterolemia 4) Patients with the value over 400mg/dL of fasting serum triglyceride. 5) Patients with history of hypersensitivity to statin. 6) Severe diabetes patients whose hemoglobin A1c are > 8.5%. 7) Active hepatic disease patients with > 100 IU/L of either ALT or AST, or with > 2.5 mg/dL of total bilirubin. 8) Patients with either <30 ml/min of creatinine clearance or > 2.0 mg/dL of serum creatinine. 9) Patients receiving cyclosporine. 10) Patients during pregnancy and with pregnant possibility. 11) Patients with hypothyroidism, hereditary myopathy (such as muscular dystrophy), a family history or a history of muscle disorder resulted from drug. 12) Patients with drug abuse or alcohol addiction. 13) Patients who are judged ineligible for any other reasons by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of amount and rate in RH-PAT index determined by EndoPAT2000 on the vascular endothelial function after 24 weeks of rousvastatin therapy

Secondary Outcome Measures

Name	Time	Method
Changes in serum lipid profile (LDL-C, TG, HDL-C), Changes in various markers ( MDA-LDL, hs-CRP, hs-cTnT ), Changes in the marker of renal function (cystatin C, urine albumin, eGFR)