Effects of aggressive lipid-lowering therapy on atherosclerosis and multi-lipoprotein profiling in patients with coronary artery disease

Effects of aggressive lipid-lowering therapy on atherosclerosis and multi-lipoprotein profiling in patients with coronary artery disease - Statin therapy against multi-lipoprotein profiling and atherosclerosis -Secondary- (SAMURAI Study -Secondary-)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002507

Enrollment

100

Registered

2009-10-01

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 coronary artery disease

Interventions

Pitavastatin 2 mg daily for a first 1-3 months. After safety evaluation, the dose will be increased to 4 mg/day in order to achieve the goal of LDL-C of 70mg/dL and less.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with coronary artery disease who meet 1 of the following 4 conditions. 1. Acute myocardial infarction occurred at least one week before. 2. Old myocardial infarction. 3. Unstable angina pectoris. 4. > or = 50% stenosis evaluated by coronary angiography (or severe stenosis evaluated by CT), or angina pectoris with ischemic ECG change (including coronary spasm). 2) Patients with hypercholesterolemia (LDL-C of 100mg/dL or more). 3) Patients 20 years or older. 4) Patients giving written consent on their own volition for participation in this clinical trial.

Exclusion criteria

Exclusion criteria: 1) Patients who have suffered from stroke for the past three months. 2) Patients who have suffered from acute myocardial infarction for the past week. 3) Patients planning CABG in the study periods. 4) Patients planning addition or change of cilostazol in the study periods 5) Patients planning CAS in the study periods 6) Patients with active malignant tumor. 7) Patients with severe renal dysfunction. 8) Patients with severe hepatic dysfunction. 9) Patients with collagen disease. 10) Patients judged as being inappropriate for this study by investigators.

Design outcomes

Primary

Measure	Time frame
Change in lipoprotein profile by LipoSEARCH. Change in brachial-ankle pulse wave velocity or cardio-ankle vascular index. Change in intima-media thickness (max IMT, mean IMT).	—

Secondary

Measure	Time frame
A percent and amount of changes in following factors. 1. Serum lipid profile (TC,LDL-C, HDL-C, TG), apolipoprotein (A1, B), and malondialdehyde-modified LDL. 2. high-sensitive CRP, adiponectin. 3. LDDd, EF, E/A, and DcT.	—

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