The Effect of DPP4 Inhibitor on Vasclular Healing

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)

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02802644

Enrollment

Registered

2016-06-16

Start date

2016-06-30

Completion date

Unknown

Last updated

2016-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Diabetes Mellitus, Type 2

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.

Interventions

DRUGSitagliptin

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

DRUGNon DPP-4 Inhibitor

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Neointimal coverage assessed by optical coherence tomography	6 months

Secondary

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

Countries

South Korea

Contacts

Primary ContactHoyoun Won, MD, PhD

nowhy@cau.ac.kr82-2-6299-2871

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026