The Effect of DPP4 Inhibitor on Vasclular Healing

NCT02802644 — Phase 4, Unknown, 66 participants, Chung-Ang University

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A Prospective, Multi-center, Randomized, Controlled Study to Evaluate the Effect of DiPeptidyl-Peptidase 4 Inhibitor on Vascular Healing After Biodegradable Polymer Based Sirolimus Eluting Stent Implantation in Diabetic Patients: OCT Study (DIAMOND-OCT)

Registry	NCT02802644
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	66 (Estimated)
Sponsor	Chung-Ang University (Other)
Conditions	Acute Coronary Syndrome, Diabetes Mellitus, Type 2
Interventions	Sitagliptin, Non DPP-4 Inhibitor (Drug)
Dates	start 2016-06-01, primary completion 2019-06-01 (estimated), first posted 2016-06-16, last updated 2016-06-16
Locations	6 sites in South Korea

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
DPP-4 Inhibitor	Experimental	Drug: Sitagliptin	Any dose of Sitagliptin for 6 months with any other oral anti-diabetic medication
Non DPP-4 Inhibitor	Active comparator	Drug: Non DPP-4 Inhibitor	Oral anti-diabetic medication except DPP-4 inhibitor

Sitagliptin (Drug), also known as Janiuvia: Sitagliptin is indicated to control hyperglycemia in type 2 diabetic patients.
Non DPP-4 Inhibitor (Drug): This group patients is permitted to take any other oral anti-hyperglycemic agents except sitagliptin.

+Outcome measures

Primary outcomes

Neointimal coverage assessed by optical coherence tomography [6 months]

Secondary outcomes

Malapposition, neointimal thickness or any optical coherence tomographic finding [6 months]
Biomarkers [6 months]: CD 34+ cell, hs CRP ect.

+Eligibility

Sex: All, ages: 20 Years to any

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)

+Locations (6)

Facility	City	Country	Status
Keimyung University Hospital	Daegu	South Korea	Not yet recruiting
Chonnam National University Hospital	Gwangju	South Korea	Not yet recruiting
Jeju National University Hospital	Jeju City	South Korea	Not yet recruiting
Chung-Ang University Hospital	Seoul	South Korea	Recruiting
Korea University Guro Hospital	Seoul	South Korea	Not yet recruiting
Ajou University Hospital	Suwon	South Korea	Not yet recruiting

+Investigators

Sang-Wook Kim, MD, PhD, Principal investigator, Chung-Ang University Hospital