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The Effect of DPP4 Inhibitor on Vasclular Healing

C

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

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)

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

Trial contacts and locations

6

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Central trial contact

Hoyoun Won, MD, PhD

Data sourced from clinicaltrials.gov

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