Acarbose for Secondary Prevention of Cardiovascular Events in Patients With Coronary Stenting and Abnormal Glucose Tolerance

UMIN ID: C000000140

Registered date:13/09/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Abnormal Glucose Tolerance
• Date of first enrollment: 2005/05/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Acarbose with a standard lifestyle modification for five years
A standard lifestyle modification for five years

Outcome(s)

• Primary Outcome: Cardiovascular event free survival time
• Secondary Outcome: 1)Conversion of abnormal glucose tolerance to type 2 diabetes 2)All cause of death 3)Occurrence of every cardiovascular event 4)Occurrence of in-stent restenosis 5)Regression of intimal plus medial complex of the carotid artery 6)Change in fasting, 2-hour blood glucose and insulin level 7)Change in homeostatis model assessment of insulin resistance 8)Change in HbA1c 9)Change in lipid profile 10)Change in high sensitive CRP 11)Change in Body Mass Index and body weight

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)Patients with abnormal glucose tolerance caused by other organic disorders such as pancreatitis, hemochromatosis, post pancreatectomy, hyperthyroidism, Cushing syndrome, Prader-Willi syndrome etc. 2)Patients with planned angioplasty. 3)Patients with uncontrollable congestive heart failure. 4)Less than 6 months since last episode of cerebral infarction. 5)Patients who have received medication for diabetes mellitus before. 6)AST(GOT) exceeding 100 IU/L or ALT(GPT) exceeding 100 IU/L. 7)Creatinine exceeding 2mg/dl. 8)Patients with a history of ileus or less than 6 months since celiotomy. 9)Pregnant women or those who plan pregnancy, or are in the lactation period. 10)Habitual drinker (more than 100ml/day of alcohol). 11)Patients with a history of gastrectomy. 12)Patients for whom it is impossible to follow up for 5 years. 13)Any other reason that the clinical supervisors or clinical researchers may have for considering a case unsuitable for the study.

Related Information

• Primary Sponsor: Institute of Biomedical Research and Innovation
• Secondary Sponsor: Translational Research Informatics Center
• Source(s) of Monetary Support: Institute of Biomedical Research and Innovation
• Secondary ID(s): BRI_CAD_04-02