NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000091

Registered date:31/08/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedDM patients(HbA1c < 6.5%) with the history of myocardial infarcion
Date of first enrollment2005/04/01
Target sample size720
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeTime 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 minimum20years-old
Age maximum79years-old
GenderMale and Female
Include criteria
Exclude criteria1.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

Contact

public contact
Name Masanori Asakura
Address 5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565 Japan 565-8565
Telephone 06-6836-0077
E-mail kitakaze@zf6.so-net.ne.jp
Affiliation Clinical Study Support Center Japan (CSSCJ) PPAR office
scientific contact
Name Masafumi Kitakaze
Address 5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565, Japan Japan
Telephone 06-6833-5012
E-mail kitakaze@zf6.so-net.ne.jp
Affiliation National Cerabral and Cardiovascular Center Cardiovascular Division