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Effects of HMG-CoA reductase inhibitor on atherosclerosis and multi-lipoprotein profiling in patients without coronary artery disease

Effects of HMG-CoA reductase inhibitor on atherosclerosis and multi-lipoprotein profiling in patients without coronary artery disease - Statin therapy against multi-lipoprotein profiling and atherosclerosis -Primary- (SAMURAI Study - Primary -)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002600
Enrollment
40
Registered
2009-10-15
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

Patients with hypercholesterolemia

Interventions

Pitavastatin 2 mg daily for 12 months.

Sponsors

Nagoya University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with hypercholesterolemia (LDL-C of 140mg/dL or more)

Exclusion criteria

Exclusion criteria: 1) Patients who have taken statins. 2) Patients who have suffered from acute myocardial infarction for the past 3 months. 3) Patients undergoing CABG or PCI for the past 3 months, or planning CABG or PCIin the study periods. 4) Patients with active malignant tumor. 5) Patients with severe renal dysfunction. 6) Patients with severe hepatic dysfunction. 7) Patients with collagen disease. 8) Patients during pregnancy and nursing. 9) Patients who do not accept informed consent. 10) Patients judged as being inappropriate for this study by investigators.

Design outcomes

Primary

MeasureTime frame
Change in endothelial function (PAT), Change in brachial-ankle pulse wave velocity or cardio-ankle vascular index, Change in intima-media thickness (max IMT, mean IMT)

Secondary

MeasureTime frame
A percent and amount of changes in following factors 1. Serum lipid profile (TC,LDL-C, HDL-C, TG), apolipoprotein (A1, B), beta-lipoprotein, lipoprotein profile by LipoSEARCH, malondialdehyde-modified LDL, CETP 2. high-sensitive CRP, adiponectin, reactive oxygen metabolites (d-ROMs), fasting inslin

Countries

Japan

Contacts

Public ContactKenji Okumura

Nagoya University, Graduate School of Medicine Department of Cardiology

kenji@med.nagoya-u.ac.jp052-744-2427

Outcome results

None listed

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