Prospective, randomized, open-label, clinical trial comparing standard and intensive LDL-lowering therapies using rosuvastatin on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties

Prospective, randomized, open-label, clinical trial comparing standard and intensive LDL-lowering therapies using rosuvastatin on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties - Prospective, randomized, open-label, clinical trial comparing standard and intensive LDL-lowering therapies with rosuvastatin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002672

Enrollment

Registered

2009-10-27

Start date

2009-10-01

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

Hypercholesterolemia

Interventions

Lowering LDL-cholesterol with rosuvastatin to minus 30%-levels which are recommended by Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases Lowering LDL-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Hypercholesterolemic patients recommended for administration of lipid-lowering agents in Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2) Patients who have aortic atherosclerotic plaques detected by MRI 3) Outpatients 4) Subjects who gave written informed consent

Exclusion criteria

Exclusion criteria: 1) Allergy against rosuvastatin 2) Poor-controlled hypertension (DBP>110 mmHg) 3) Poor-controlled diabetes (HbA1c>10.0 %) 4) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 5) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 6) Chronic renal failure (serum creatinine>2.0 mg/dl) 7) Malignancies or other diseases with poor prognosis 8) Pregnant 9) Subjects whose doctor in charge do not agree to join the trial

Design outcomes

Primary

Measure	Time frame
Area of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI), 12/24 months after randomization Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6/12/24 months after randomization Flow-mediated vasodilation in forearm, 6 months after randomization Heparin-releasable EC-SOD levels, 6 months after randomization	—

Secondary

Measure	Time frame
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria), 6/12/24 months after randomization	—

Countries

Japan

Contacts

Public ContactMakoto Ayaori

National Defense Medical College Department of Internal Medicine I

ayaori@ndmc.ac.jp04-2995-1597

Outcome results

None listed

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