Prevention and regression of carotid artery IMT with Cilostazol and Pioglitazone use in atherosclerosis with type 2 diabetes

UMIN ID: UMIN000001729

Registered date:01/03/2009

Basic Information

• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 2009/03/01
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Group A Follow up 2-year prospective follow-up study Dose Cilostazol 100-200mg/day, Pioglitazone 15-30 mg/day, Aspirin 100-300 mg/day Measure IMT; After 0,6,12,24 Month
Group B Follow up 2-year prospective follow-up srudy Dose; Pioglitazone 15-30 mg/day, Aspirin 100-300 mg/day Measure IMT After 0,6,12,24 Month

Outcome(s)

• Primary Outcome: Absolute change of carotid Max-IMT

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. HbA1c and over 10% 2. Medical history or presumptive of carotid arterial reconstruction 3. BNP and over 100 4. Early stage of stroke 5. Arterial fibrillation 6. Under anti-platelet therapy other than aspirin 7. Receiving warfarin-potassium therapy 8. Congestive heart failure 9. Severe hepatic disfunction or renal disfunction 10. Severe infections disease, injury, pre or post operation 11. Severe ketosis, diabetic coma, type 1 diabetes mellitus 12. Pts who are bleeding 13. Drug allergies or medical history of hypersensitivity to the investigational drugs 14. Pregnant or lactating women, or women who wish to become pregnant 15. Others whom the investigator judges inappropriate as subjects for this study

Related Information

• Primary Sponsor: CHIBAKEN SAISEIKAI NARASINO HOSPITAL internal medicine
• Source(s) of Monetary Support: FAIS