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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010040

Enrollment

Registered

2013-03-01

Start date

2012-12-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

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

Interventions

rosuvastatin 2.5-20mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Dyslipidemia (untreated patients: LDL-C > 100 mg/dL, treated patients: LDL-C value does not matter, but the patient treated with rosuvastatin should be excluded.) 2) Outpatient > 20 years old (at obtaining the informed consent), and gender is unquestioned. 3) The patients who we can obtain the informed consent signed by themselves.

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)	—

Countries

Japan

Contacts

Public ContactTadateru Takayama

Nihon University School of Medicine Division of Cardiology

takayama.tadateru@nihon-u.ac.jp03-3972-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026