The Effect of DPP4 Inhibitor on Vasclular Healing

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02802644
• Other study ID #: CAU001
• Status: Recruiting
• Phase: Phase 4
• First received: June 13, 2016
• Last updated: June 13, 2016
• Start date: June 2016

Study information

• Verified date: June 2016
• Source: Chung-Ang University
• Contact: Hoyoun Won, MD, PhD
• Phone: 82-2-6299-2871
• Email: nowhy[@]cau.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Sitagliptin
Sitagliptin is indicated to control hyperglycemia in type 2 diabetic patients.
• Non DPP-4 Inhibitor
This group patients is permitted to take any other oral anti-hyperglycemic agents except sitagliptin.

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Hospital	Daegu
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Jeju National University Hospital	Jeju
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neointimal coverage assessed by optical coherence tomography		6 months	No
Secondary	Malapposition, neointimal thickness or any optical coherence tomographic finding		6 months	No
Secondary	Biomarkers	CD 34+ cell, hs CRP ect.	6 months	No