- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02802644
The Effect of DPP4 Inhibitor on Vasclular Healing
June 13, 2016 updated by: Sang-Wook Kim, Chung-Ang University
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)
This study evaluate the effect of dipeptidyl-peptidase 4 inhibitor on vascular healing after biodegradable polymer based sirolimus eluting stent implantation in diabetic pateints.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
66
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hoyoun Won, MD, PhD
- Phone Number: 82-2-6299-2871
- Email: nowhy@cau.ac.kr
Study Locations
-
-
-
Daegu, Korea, Republic of
- Not yet recruiting
- Keimyung University Hospital
-
Principal Investigator:
- Chang-Wook Nam, MD, PhD
-
Gwangju, Korea, Republic of
- Not yet recruiting
- Chonnam National University Hospital
-
Jeju, Korea, Republic of
- Not yet recruiting
- Jeju National University Hospital
-
Principal Investigator:
- Ki-Seok Kim, MD, PhD
-
Seoul, Korea, Republic of, 06973
- Recruiting
- Chung-Ang University Hospital
-
Principal Investigator:
- Sang-Wook Kim, MD, PhD
-
Seoul, Korea, Republic of
- Not yet recruiting
- Korea University Guro Hospital
-
Principal Investigator:
- Seung-Woon Rha, MD, PhD
-
Suwon, Korea, Republic of
- Not yet recruiting
- Ajou University Hospital
-
Principal Investigator:
- So-Yeon Choi, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DPP-4 Inhibitor
Any dose of Sitagliptin for 6 months with any other oral anti-diabetic medication
|
Sitagliptin is indicated to control hyperglycemia in type 2 diabetic patients.
Other Names:
|
Active Comparator: Non DPP-4 Inhibitor
Oral anti-diabetic medication except DPP-4 inhibitor
|
This group patients is permitted to take any other oral anti-hyperglycemic agents except sitagliptin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neointimal coverage assessed by optical coherence tomography
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Malapposition, neointimal thickness or any optical coherence tomographic finding
Time Frame: 6 months
|
6 months
|
|
Biomarkers
Time Frame: 6 months
|
CD 34+ cell, hs CRP ect.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sang-Wook Kim, MD, PhD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Anticipated)
June 1, 2019
Study Registration Dates
First Submitted
June 13, 2016
First Submitted That Met QC Criteria
June 13, 2016
First Posted (Estimate)
June 16, 2016
Study Record Updates
Last Update Posted (Estimate)
June 16, 2016
Last Update Submitted That Met QC Criteria
June 13, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Acute Coronary Syndrome
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Sitagliptin Phosphate
Other Study ID Numbers
- CAU001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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