Study on Therapeutic Effects of Antiplatelet Drugs in Prevention of Occurrence and Inhibition of Progression of Diabetic Atherosclerosis

UMIN ID: C000000215

Registered date:01/10/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Diabetes
• Date of first enrollment: 2004/12/01
• Target sample size: 400
• Countries of recruitment: Japan,Asia(except Japan)
• Study type: Interventional

Intervention(s)

Aspirin group (81-100mg/day) 2 years
Cilostazol group (100-200,g/day) 2 years

Outcome(s)

• Primary Outcome: Change of maximum and mean intima-media thickness (IMT) in bilateral common carotid artery.

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1 Patients with type 1 diabetes or secondary diabetes 2 Patients aged under 40 years old, or over 76 years old 3 Patients with severe ASO rated as Fontaine IIb or over 4 Patients with cerebrovascular disorders rated as Grade 4 or over in Modified Rankin Scale (Severe disorder which needs assistance for personal care and walk) 5 Patients with a medical history of angina or myocardial infarction 6 Patients with severe hepatic dysfunction (liver cirrhosis) or renal dysfunction (serum creatinine 1.5mg/dl) 7 Patients with congestive heart failure 8 Patients with bleeding tendency or bleeding 9 Patients with severe hematological abnormality 10 Patients with definite homologousfamilial hypercholesterolemia 11 Patients who have allergies or a medical history of hypersensitivity to the investigational drugs 12 Pregnant or lactating women, or women who wish to become pregnant 13 Others whom the investigator judges inappropriate as subjects for this study

Related Information

• Primary Sponsor: DAPC Study Steering Committee
• Source(s) of Monetary Support: Japan Cardiovascular Research Foundation