The Effect of DPP4 Inhibitor on Vasclular Healing

NCT ID: NCT02802644

Last Updated: 2016-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Brief Summary

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

Detailed Description

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Conditions

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Acute Coronary Syndrome Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DPP-4 Inhibitor

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

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

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

Non DPP-4 Inhibitor

Oral anti-diabetic medication except DPP-4 inhibitor

Group Type ACTIVE_COMPARATOR

Non DPP-4 Inhibitor

Intervention Type DRUG

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

Interventions

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Sitagliptin

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

Intervention Type DRUG

Non DPP-4 Inhibitor

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

Intervention Type DRUG

Other Intervention Names

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Janiuvia

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung-Ang University

OTHER

Sponsor Role lead

Responsible Party

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Sang-Wook Kim

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang-Wook Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Keimyung University Hospital

Daegu, , South Korea

Site Status NOT_YET_RECRUITING

Chonnam National University Hospital

Gwangju, , South Korea

Site Status NOT_YET_RECRUITING

Jeju National University Hospital

Jeju City, , South Korea

Site Status NOT_YET_RECRUITING

Chung-Ang University Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Ajou University Hospital

Suwon, , South Korea

Site Status NOT_YET_RECRUITING

Countries

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South Korea

Central Contacts

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Hoyoun Won, MD, PhD

Role: CONTACT

82-2-6299-2871

Other Identifiers

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CAU001

Identifier Type: -

Identifier Source: org_study_id

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