The Effect of DPP4 Inhibitor on Vasclular Healing

Phase 4

• Conditions: Diabetes Mellitus, Type 2; Acute Coronary Syndrome
• Interventions: Drug: Non DPP-4 Inhibitor; Drug: Sitagliptin

• Registration Number: NCT02802644
• Lead Sponsor: Chung-Ang University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-13
• Last Update Submitted: 2016-06-13
• Study First Posted: 2016-06-16
• Last Update Posted: 2016-06-16
• Primary Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Non-ST segement elevation acute coronary syndrome

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non DPP-4 Inhibitor	Non DPP-4 Inhibitor	Oral anti-diabetic medication except DPP-4 inhibitor
DPP-4 Inhibitor	Sitagliptin	Any dose of Sitagliptin for 6 months with any other oral anti-diabetic medication

Primary Outcome Measures

Name	Time	Method
Neointimal coverage assessed by optical coherence tomography	6 months

Secondary Outcome Measures

Name	Time	Method
Malapposition, neointimal thickness or any optical coherence tomographic finding	6 months
Biomarkers	6 months	CD 34+ cell, hs CRP ect.

Trial Locations

Locations (6)

Keimyung University Hospital; 🇰🇷 Daegu, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of

Jeju National University Hospital; 🇰🇷 Jeju, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of