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)
1 other identifier
interventional
66
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 13, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedJune 16, 2016
June 1, 2016
3 years
June 13, 2016
June 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Neointimal coverage assessed by optical coherence tomography
6 months
Secondary Outcomes (2)
Malapposition, neointimal thickness or any optical coherence tomographic finding
6 months
Biomarkers
6 months
Study Arms (2)
DPP-4 Inhibitor
EXPERIMENTALAny dose of Sitagliptin for 6 months with any other oral anti-diabetic medication
Non DPP-4 Inhibitor
ACTIVE COMPARATOROral anti-diabetic medication except DPP-4 inhibitor
Interventions
Sitagliptin is indicated to control hyperglycemia in type 2 diabetic patients.
This group patients is permitted to take any other oral anti-hyperglycemic agents except sitagliptin.
Eligibility Criteria
You may qualify if:
- Non-ST segement elevation acute coronary syndrome
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Keimyung University Hospital
Daegu, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Jeju National University Hospital
Jeju City, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Korea University Guro Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang-Wook Kim, MD, PhD
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 13, 2016
First Posted
June 16, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2019
Last Updated
June 16, 2016
Record last verified: 2016-06