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Randomized control trial of effect of cholesterol absorption with ischemic heart disease patients.

Randomized control trial of effect of cholesterol absorption with ischemic heart disease patients. - Ezetimibe and Statin Saved Endothelial Function Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002297
Enrollment
250
Registered
2009-08-10
Start date
2009-09-01
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.

Interventions

Add ezetimibe 10mg daily. Add atorvastatin 10mg daily.

Sponsors

Kameda General Hospital, department of cardiology.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who treated with atorvastatin 10mg daily, and meet all of the following criterias; 1. LDL-Cholesterol over 70mg/dL. 2. Patients with ischemic heart disease. 3. Patients over 20 years old. 4. Patients who do not changed lipid altering agents in 4 weeks. 5. Patients who do not changed antidiabetes agent in 12 weeks, and has no remarkable change in glucose metabolism.

Exclusion criteria

Exclusion criteria: 1. Patients who treated with insulin therapy. 2. HbA1c over 9%. 3. Patients who diagnosed of acute coronary syndrome in one month. 4. Patients who had history of anaphylaxis to the ezetimibe or atorvastatin. 5. AST over 100 IU/l or 127 IU/l. 6. Patients with secondary hyperlipidemia of drug-induced hyperlipidemia. 7. Patients who is pregnant or lactating. 8. Familial hyperlipidemia. 9. Other conditions precluding participation as judged by the investigator.

Design outcomes

Primary

MeasureTime frame
Percent change of endothelial function.

Secondary

MeasureTime frame
Comparison between two groups of serum lipid profile, adipocytokine, oxidative-stress and inframmatory marker, expression frequency of adverse effect due to the drugs.

Countries

Japan

Contacts

Public ContactYuya MATSUE, M.D.

Kameda General Hospital. Department of Cardiology.

yuyam@kameda.jp

Outcome results

None listed

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