acute coronary syndrome requiring coronary stent implantation in patients with type 2 diabetes
Conditions
Interventions
For Type 2 diabetic patients (HbA1c level: 6.5%-9.0%) with acute coronary syndrome, who had undergone coronary intervention with bare metal stent (Liberte
Coronary Stent System), Sitagliptin Phosphate Hydrate (DPP-4 Inhibitor) is initiated at a dose of 50mg per day post stenting and titrated up as needed to 100mg per day to reach the target level of HbA
Coronary Stent System), conventional antidiabetic agent is initiated to reach the target level of HbA1c within 6.5%. Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 8 months will be estima
Sponsors
Association of Kansai Cardiovascular Treatment Study
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with acute coronary syndrome, who had undergone percutaneous coronary intervention with bare metal stent (Liberte; Coronary Stent System) 2)Patients, whose left main trunk or the other coronary stem than ostial of each coronary artery are treated. 3)Patients who are treated with single stent. 4)Patients who are treated with the under 3.5mm sized stents. 5)Patients who fit one of following three cases, as well as who are diagnosed as type 2 diabetic patients of not being well controlled.* *Type 2 diabetic patients whose latest HbA1c are above 6.5%, under 9.0%. *Type 2 diabetic patients who have above 126mg/dl in their interdigestive rate or above 200mg/dl in the rate after 2 hours of glucose tolerance test or regularly. *Type 2 diabetic patients who has been already taking diabetes drug, and 5.8% above in HbA1c. (= well controlled HbA1c) 6)Patients over 20 years old, under 80 years old. 7)Patients with written agreements.(signed contracts)
Exclusion criteria
Exclusion criteria: 1)Type 1 diabetic patients 2) Patients who have histories of serious ketosis, diabetic coma or entire coma within 6 months. 3)Patients with serious infections, or before and after the operations, or who have serious/critical external injuries. 4)Patients with moderate to severe renal insufficiency. (serum creatinine level: 1.5mg/dL or above (male), 1.3mg/dL or above (female) 5)Patients with serious/critical valve diseases such as mitral stenosis or aortic regurgitation. 6)Patients who are prescribed some DPP-4 inhibitory drug other than Sitagliptin. 7)Patients who are continuously prescribed glinide and insulin, when the researching drug (Sitagliptin) is administered. 8)Patients of over 140mg/dL in their LDL-C rates. 9)Women during lactation, pregnant women and women suspected of being pregnant 10)Patients who have histories of hypersensitivity to researching drug. 11)Patients who are not available for administration of anti-thrombotic medicines. 12)Any other patients who are evaluated as inappropriate by the doctor in attendance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac and Cerebrovascular Events (MACCE) | — |
Secondary
| Measure | Time frame |
|---|---|
| intimal thickness at 8 months evaluated by IVUS, OCT and carotid vascular echography | — |
Countries
Japan
Contacts
Public ContactShigeru Nakamura
Kyoto Katsura Hospital Cardiovascular Center
Outcome results
None listed