Pioglitazone Intervention for Coronary Atherosclerosis in Patients with Metabolic Syndrome.

UMIN ID: C000000332

Registered date:03/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Coronary atherosclerosis Metabolic syndrome
• Date of first enrollment: 2006/03/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Piogllitazone 30mg/day
Valsartan 40-80mg/day

Outcome(s)

• Primary Outcome: Change in volume of coronary atherosclerotic plaque evaluated by intravascular ultrasound Change in tissue components of coronary atherosclerotic plaque evaluated by intravascular ultrasound Change in plasma lipid profile Change in inflammatory markers
• Secondary Outcome: Death, Acute coronary syndrome, Newly onset of angina whose culprit lesion is subjective plaque, Severe heart failure

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Acute coronary syndrome (acute myocardial infarction / unstable angina) Undergo insulin therapy Severe liver dysfunction, severe renal dysfunction Undergo treatment of heart failure Already taking pioglitazone History of side effect of thiazolidines CD36 defficiency Pregnancy or possible pregnancy Non-hypertension

Related Information

• Primary Sponsor: Department of Cardiovascular Medicine Saitama Medical University International Medical Center
• Source(s) of Monetary Support: Department of Cardiovascular Medicine Saitama Medical University International Medical Center