The Effect of DPP4 Inhibitor on Vasclular Healing

June 13, 2016 updated by: Sang-Wook Kim, Chung-Ang University

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)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Not yet recruiting
        • Keimyung University Hospital
        • Principal Investigator:
          • Chang-Wook Nam, MD, PhD
      • Gwangju, Korea, Republic of
        • Not yet recruiting
        • Chonnam National University Hospital
      • Jeju, Korea, Republic of
        • Not yet recruiting
        • Jeju National University Hospital
        • Principal Investigator:
          • Ki-Seok Kim, MD, PhD
      • Seoul, Korea, Republic of, 06973
        • Recruiting
        • Chung-Ang University Hospital
        • Principal Investigator:
          • Sang-Wook Kim, MD, PhD
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Korea University Guro Hospital
        • Principal Investigator:
          • Seung-Woon Rha, MD, PhD
      • Suwon, Korea, Republic of
        • Not yet recruiting
        • Ajou University Hospital
        • Principal Investigator:
          • So-Yeon Choi, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DPP-4 Inhibitor
Any dose of Sitagliptin for 6 months with any other oral anti-diabetic medication
Drug: Sitagliptin
Sitagliptin is indicated to control hyperglycemia in type 2 diabetic patients.
Other Names:
  • Janiuvia
Active Comparator: Non DPP-4 Inhibitor
Oral anti-diabetic medication except DPP-4 inhibitor
Drug: Non DPP-4 Inhibitor
This group patients is permitted to take any other oral anti-hyperglycemic agents except sitagliptin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neointimal coverage assessed by optical coherence tomography
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Malapposition, neointimal thickness or any optical coherence tomographic finding
Time Frame: 6 months
6 months
Biomarkers
Time Frame: 6 months
CD 34+ cell, hs CRP ect.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung-Ang University

Investigators

  • Principal Investigator: Sang-Wook Kim, MD, PhD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAU001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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