The Effect of DPP4 Inhibitor on Vasclular Healing

Chung-Ang University

Status and phase: Unknown; Phase 4

Conditions: Acute Coronary Syndrome; Diabetes Mellitus, Type 2

Treatments: Drug: Sitagliptin; Drug: Non DPP-4 Inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT02802644

CAU001

Details and patient eligibility

About

This study evaluate the effect of dipeptidyl-peptidase 4 inhibitor on vascular healing after biodegradable polymer based sirolimus eluting stent implantation in diabetic pateints.

Enrollment: 66 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-ST segement elevation acute coronary syndrome

Exclusion criteria

• Left main disease
• Known hypersensitivity or contraindication to any of the following medications: Heparin, aspirin, clopidogrel, sirolimus, siptagliptin and statin
• Congestive heart failure (patients with LVEF <30% or cardiogenic shock)
• Uncontrolled myocardial ischemia (repeated chest pain or dyspnea after revascularization)
• Uncontrolled ventricular arrhythmia
• History of malignancy with chemotherapy
• Serious hematologic disease (e.g. CML, MDS)
• Current infectious disease needs antibiotics therapy
• Creatinine level >1.5 mg/dL or dependence on dialysis
• Other severe concurrent illness (e.g. active infection, malignancy).
• Life expectancy of less than one year
• Pregnancy or women with potential childbearing
• Type I DM
• Treatment with insulin
• History of pancreatitis
• Who cannot read the informed consent form (e.g. illiteracy, foreigner)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

DPP-4 Inhibitor

Experimental group

Description:

Any dose of Sitagliptin for 6 months with any other oral anti-diabetic medication

Treatment:

Drug: Sitagliptin

Non DPP-4 Inhibitor

Active Comparator group

Description:

Oral anti-diabetic medication except DPP-4 inhibitor

Treatment:

Drug: Non DPP-4 Inhibitor