The Effect of Alogliptin on Cardiovascular Disease in Patients with Acute Coronary Syndromes

Not Applicable

• Conditions: Acute coronary syndromes

• Registration Number: JPRN-UMIN000010093
• Lead Sponsor: Yokohama City University Medical Center

Brief Summary

Alogliptin treatment, independently of glycemic and lipid status, resulted in significant plaque regression and stabilization in non-culprit coronary lesions in patients with acute coronary syndrome and mild dysglycemia. Atherosclerosis. 2022 Nov;360:1-7.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-22
• Study Completion: 2018-10-01
• Results First Posted: 2022-09-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absolute and normalized plaque volume and percent changes in plaque volume as well as plaque characteristics assessed by IVUS.

Secondary Outcome Measures

Name	Time	Method
*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.