Pioglitazone Intervention for Coronary Atherosclerosis in Patients with Acute Coronary Syndrome.

UMIN ID: C000000344

Registered date:03/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Acute coronary syndrome
• Date of first enrollment: 2006/04/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Pioglitazone 30mg/day Fluvastatin 20mg/day
Fluvastatin 20mg/day

Outcome(s)

• Primary Outcome: Change in volumes of coronary atherosclerotic plaques evaluated by intravascular ultrasound Change in histological components of coronary atherosclerotic plaques evaluated by intravascular ultrasound Change in plasma lipid profile Change in plasma inflammatory markers
• Secondary Outcome: Death, Acute myocardial infarction, Onset of angina whose culprit lesion is subjective coronary plaque, Severe heart failure

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: LVEF < 40% Newly onset of congestive heart failure Treatment with insulin Type 1 diabetes Severe liver dysfunction, severe renal dysfunction Already treatment with pioglitazone History of side effects of thiazolidines CD36 defficiency Pregnancy or possible pregnancy A case whose attending physician decides he is not a candidate for the study by any reason.

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