Randomized trial of Lipid lowering Therapy for Endothelial Function;Statin Monotherapy Compared with Statin/Ezetimibe or Statin/Eicosapentaenoic Acid Combination Therapy

Randomized trial of Lipid lowering Therapy for Endothelial Function;Statin Monotherapy Compared with Statin/Ezetimibe or Statin/Eicosapentaenoic Acid Combination Therapy - Rapid Estimate

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008060

Enrollment

Registered

2012-05-31

Start date

2012-06-01

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

Ischemic heart disease, Coronary atherosclerosis

Interventions

Administration of atorvastatin 20mg for 6 months Administration of atorvastatin 10mg plus ezetimibe 5mg for 6 months Administration of atorvastatin 10mg plus ezetimibe 10mg for 6 months Administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with ischemic heart disease or coronary atherosclelosis. 2.LDL cholesterol level is from 100mg/dl to 120mg/dl with 10mg of atorvastatin. 3.No drug change during latest 3 months. 4.No history of revascularization during latest 3 months.

Exclusion criteria

Exclusion criteria: 1.Patients with liver disease (ALT or AST level is over 100IU/L, total Bil level is over 2.5mg/dl). 2.Patients with renal insufficiency (serum creatinine level is over 2.0mg/dl, or creatinine clearance is under 30mL/min/1.73m2). 3.Patients with congenital heart disease. 4.Patients within 3 months from myocardial infarction and with highly advanced cardiac dysfunction. 5.Patients with endocrine disease. 6.Patients with malignancy or inflammatory disease. 7.Patinets with highly advanced respiratory disease (containing pulmonary arterial pulmonary hypertension. 8.Patients with cranial nerve disease or locomotor apparatus disease, and severely compromised daily life. 9.Patients with severe hypertension. 10.Patients administrated steroid or immune suppressor. 11.Patients with type1 DM or poorly controled type2 DM(FBS>200mg/dl, HbA1c>10.0%) 12.Patients during pregnancy or with possibility of pregnancy. 13.Patients administrated catecholamine. 14.Patients with symptomatic hypotension. 15.Patients with significant LVOT obstruction (Hypertrophic obstructive cardiomyopathy or aortic stenosis). 16.Patients recognized inadequate by primary doctor.

Design outcomes

Primary

Measure	Time frame
Improvement of endothelial function	—

Secondary

Measure	Time frame
small dense LDL, high sensitivity CRP, oxidized LDL(MDA-LDL), pentraxin 3, high-molecular weight adiponectin, apolipoprotein A-1/B	—

Countries

Japan

Contacts

Public ContactTaku Koyama

Fukuoka wajiro hospital Cardiology

taku-koyama@umin.ac.jp092-608-0001

Outcome results

None listed

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