The Effect of DPP4 Inhibitor on Vasclular Healing | NCT02802644

Studies
The Effect of DPP4 Inhibitor on Vasclular Healing

NCT02802644

Sponsor

Chung-Ang University

Status

Unknown status

Last Update Posted

Jun 16, 2016Estimated

Enrollment

66Estimated

Phase

Phase 4

Conditions

Acute Coronary Syndrome
Diabetes Mellitus, Type 2

Interventions

Sitagliptin
Non DPP-4 Inhibitor

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jun 2019Estimated

Completion Date

Not provided

First Submitted Date

Jun 13, 2016

First Submission Date that Met QC Criteria

Jun 13, 2016

First Posted Date

Jun 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2016

Last Update Posted Date

Jun 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DPP-4 Inhibitor	Experimental	Any dose of Sitagliptin for 6 months with any other oral anti-diabetic medication	Drug: Sitagliptin
Non DPP-4 Inhibitor	Active Comparator	Oral anti-diabetic medication except DPP-4 inhibitor	Drug: Non DPP-4 Inhibitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sitagliptin	Drug	Sitagliptin is indicated to control hyperglycemia in type 2 diabetic patients.	DPP-4 Inhibitor

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hoyoun Won, MD, PhD	Contact	82-2-6299-2871		nowhy@cau.ac.kr

Overall Officials

Name	Affiliation	Role
Sang-Wook Kim, MD, PhD	Chung-Ang University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Keimyung University Hospital	Not yet recruiting	Daegu			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068900	Sitagliptin Phosphate

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided