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

UMIN ID: UMIN000002297

Registered date:10/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Ischemic heart disease.
• Date of first enrollment: 2009/09/01
• Target sample size: 250
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Percent change of endothelial function.
• Secondary Outcome: Comparison between two groups of serum lipid profile, adipocytokine, oxidative-stress and inframmatory marker, expression frequency of adverse effect due to the drugs.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Kameda General Hospital, department of cardiology.
• Source(s) of Monetary Support: Tokyo Medical Dental University, Bioethics Research Center.