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The Effect of DPP4 Inhibitor on Vasclular Healing

Primary Purpose

Acute Coronary Syndrome, Diabetes Mellitus, Type 2

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Sitagliptin

Non DPP-4 Inhibitor

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Keimyung University Hospital
Chonnam National University Hospital
Jeju National University Hospital
Chung-Ang University HospitalRecruiting
Korea University Guro Hospital
Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DPP-4 Inhibitor

Non DPP-4 Inhibitor

Arm Description

Any dose of Sitagliptin for 6 months with any other oral anti-diabetic medication

Oral anti-diabetic medication except DPP-4 inhibitor

Outcomes

Primary Outcome Measures

Neointimal coverage assessed by optical coherence tomography

Secondary Outcome Measures

Malapposition, neointimal thickness or any optical coherence tomographic finding

Biomarkers

CD 34+ cell, hs CRP ect.

Full Information

NCT ID

NCT02802644

First Posted

June 13, 2016

Last Updated

June 13, 2016

Sponsor

Chung-Ang University

1. Study Identification

Unique Protocol Identification Number

NCT02802644

Brief Title

The Effect of DPP4 Inhibitor on Vasclular Healing

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 Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

June 2019 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chung-Ang University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DPP-4 Inhibitor

Arm Type

Experimental

Arm Description

Any dose of Sitagliptin for 6 months with any other oral anti-diabetic medication

Arm Title

Non DPP-4 Inhibitor

Arm Type

Active Comparator

Arm Description

Oral anti-diabetic medication except DPP-4 inhibitor

Intervention Type

Drug

Intervention Name(s)

Sitagliptin

Other Intervention Name(s)

Janiuvia

Intervention Description

Sitagliptin is indicated to control hyperglycemia in type 2 diabetic patients.

Intervention Type

Drug

Intervention Name(s)

Non DPP-4 Inhibitor

Intervention Description

This group patients is permitted to take any other oral anti-hyperglycemic agents except sitagliptin.

Primary Outcome Measure Information:

Title

Neointimal coverage assessed by optical coherence tomography

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Malapposition, neointimal thickness or any optical coherence tomographic finding

Time Frame

6 months

Title

Biomarkers

Description

CD 34+ cell, hs CRP ect.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hoyoun Won, MD, PhD

Phone

82-2-6299-2871

nowhy@cau.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang-Wook Kim, MD, PhD

Organizational Affiliation

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Keimyung University Hospital

City

Daegu

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chang-Wook Nam, MD, PhD

Facility Name

Chonnam National University Hospital

City

Gwangju

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Young Joon Hong, MD, PhD

Facility Name

Jeju National University Hospital

City

Jeju

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ki-Seok Kim, MD, PhD

Facility Name

Chung-Ang University Hospital

City

Seoul

ZIP/Postal Code

06973

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sang-Wook Kim, MD, PhD

Facility Name

Korea University Guro Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seung-Woon Rha, MD, PhD

Facility Name

Ajou University Hospital

City

Suwon

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

So-Yeon Choi, MD, PhD

12. IPD Sharing Statement

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The Effect of DPP4 Inhibitor on Vasclular Healing

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