The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction

UMIN ID: C000000091

Registered date:31/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: DM patients(HbA1c < 6.5%) with the history of myocardial infarcion
• Date of first enrollment: 2005/04/01
• Target sample size: 720
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Participants in the pioglitazone group were administered a pioglitazone tablet (15 mg) once a day. In the event of the side effects such as oedema, the dosage of pioglitazone was reduced to half or a quarter of the original dosage. Otherwise, we tried to increase the dose of pioglitazone to 30mg/day.
In control group, (1)each participated doctor (1)instructs weight reduction, appropriate diet, regular exercise and/or (2)prescribes sulfonylurea agents.

Outcome(s)

• Primary Outcome: Time till the first cardiovascular composite endpoint of death from cardiovascular death, and the hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina, treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft) and cerebral infarction.
• Secondary Outcome: (1) All cause mortality (2) Hospitalization due to either of the component of primary endpoints (3) Progression of diabetes (HbA1C levels > 7.0%) (4) worsening of renal function ((1) All cause mortality (2) Hospitalization due to either of the component of primary endpoints (3) Progression of diabetes (HbA1C levels less than 7.0%) (4) worsening of renal function (serum creatine levels =>2.5mg/dL or the increases of serum creatine levels by =>2mg/dL)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: 1.Symptomatic CHF 2.Type I diabetes 3.History of coronary artery bypass graft 4.Severe liver and/or kidney dysfunction 5.History of allergic response to drugs 6.arteriosclerosis obliterans

Related Information

• Primary Sponsor: Department of Clinical Meidicine and Development, National Cerebral and Cardiovascular Center
• Source(s) of Monetary Support: Japan Heart Foundation