Acute coronary syndromes
Conditions
Interventions
Alogliptin treatment
Additional treatment with alogliptin 25mg/day for 10+or-2 months (study period). Glycemic control goal (target HbA1c levels):6.5%/JDS (6.9%/NGSP).
Treatment without alogliptin (other DPP-4 inhibit
Glucose lowering therapy without DPP-4 inhibitors/GLP-1 analogues in the study period. Glycemic control goal (target HbA1c levels):6.5%/JDS (6.9%/NGSP).
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with acute coronary syndrome (defined as ST-segment elevation acute myocardial infarction, non-ST-segment elevation myocardial infarction or unstable angina). Patients who meet at least two of the following criteria within 28 days prior to admission: 1. ECG changes of acute coronary ischemia 2. Serum CK level more than 2 times the upper limit of normal, serum CK-MB or troponin (T/I) over the above upper limit of normal, or positivity for serum troponin T or I by a rapid, qualitative assay 3. Clinical history or evident pphysiological findings of acute coronary syndromes. 2) Patients who have at least one coronary plaque of 25% diameter stenosis or more in the culprit vessel, the target plaque needs to be 5 mm or more depart from the culprit lesion for PCI, or at the non-culprit lesion/vessels). 3) Patinets with dysglycemia defined by the criteria of the Japanese Diabetes Society. 4) Patients 20 years old or older at the time of consent. 5) Patients providing written consent for participation in this clinical trial on their own volition after receiving a thorough explanation about the study.
Exclusion criteria
Exclusion criteria: 1) Patients with cancer, severe infectious disease, traumatic disease or hypersensitivity to test drug, and patients who are judged by the principal or other investigator to be ineligible for enrollment in the study. 2) Patients pretreated with DPP-4 inhibitors or GLP-1 analogues. 3) Target PCI lesion is graft stenosis or in-stent restenosis. 4) Patients who had undergone previous PCI for the lesion under investigation. 5) Patients with cardiogenic shock 6) Patients on cyclosporine therapy 7) Patients with liver dysfunction (ALT[GPT] >= 100IU), biliary obstruction and/or defective hepatic metabolism: acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, hepatic carcinoma and/or icterus. 8) Pregnant and possibly pregnant women, lactating women. 9) Patients on maintenance dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute and normalized plaque volume and percent changes in plaque volume as well as plaque characteristics assessed by IVUS. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Changes in plaque characteristics including coronary fibrous-cap thickness assessed by OCT, *Changes in MLD and % stenosis, *Frequency of periprocedual myocardial infarction, *Changes in inframmatory markers (hs-CRP, MMP9, IL6, etc) and lipid/glycemic status (including CGM data), *Changes in endothelial function assessed by Endo-PAT 2000, *Changes in echographic parameters (cardiac function, IMT etc), *MRI parameters including LGE, peri/para-cardial fat. *Changes in oxidative stress markers, *Prognosis (death, ACS, heart failure, restenosis, stroke, etc), *Changes in ABPM parameters, ectopic fat assessed by Abdominal CT and DEXA. | — |
Countries
Japan
Contacts
Public ContactKouzou Okada
Yokohama City University Medical Center Division of Cardiology
Outcome results
None listed