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The Effect of DPP4 Inhibitor on Vasclular Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02802644
Recruitment Status : Unknown
Verified June 2016 by Sang-Wook Kim, Chung-Ang University.
Recruitment status was:  Recruiting
First Posted : June 16, 2016
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
Sang-Wook Kim, 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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Diabetes Mellitus, Type 2 Drug: Sitagliptin Drug: Non DPP-4 Inhibitor Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Neointimal coverage assessed by optical coherence tomography [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Malapposition, neointimal thickness or any optical coherence tomographic finding [ Time Frame: 6 months ]
  2. Biomarkers [ Time Frame: 6 months ]
    CD 34+ cell, hs CRP ect.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802644


Contacts
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Contact: Hoyoun Won, MD, PhD 82-2-6299-2871 nowhy@cau.ac.kr

Locations
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Korea, Republic of
Keimyung University Hospital Not yet recruiting
Daegu, Korea, Republic of
Principal Investigator: Chang-Wook Nam, MD, PhD         
Chonnam National University Hospital Not yet recruiting
Gwangju, Korea, Republic of
Principal Investigator: Young Joon Hong, MD, PhD         
Jeju National University Hospital Not yet recruiting
Jeju, Korea, Republic of
Principal Investigator: Ki-Seok Kim, MD, PhD         
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of, 06973
Principal Investigator: Sang-Wook Kim, MD, PhD         
Korea University Guro Hospital Not yet recruiting
Seoul, Korea, Republic of
Principal Investigator: Seung-Woon Rha, MD, PhD         
Ajou University Hospital Not yet recruiting
Suwon, Korea, Republic of
Principal Investigator: So-Yeon Choi, MD, PhD         
Sponsors and Collaborators
Chung-Ang University
Investigators
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Principal Investigator: Sang-Wook Kim, MD, PhD Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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Responsible Party: Sang-Wook Kim, MD, PhD, Chung-Ang University
ClinicalTrials.gov Identifier: NCT02802644    
Other Study ID Numbers: CAU001
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sitagliptin Phosphate
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action