Acute Coronary SyndromePhase 4NCT02802644
The Effect of DPP4 Inhibitor on Vasclular Healing
A Phase 4 study testing Sitagliptin and Non DPP-4 Inhibitor in people with Acute Coronary Syndrome and Diabetes Mellitus, Type 2, run by Chung-Ang University at 6 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Diabetes Mellitus, Type 2
- What is being tested?
- Sitagliptin and Non DPP-4 Inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Jun 2016to Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-ST segement elevation acute coronary syndrome
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Not yet recruiting
Keimyung University Hospital
Daegu
Chang-Wook Nam, MD, PhD
- Not yet recruiting
Chonnam National University Hospital
Gwangju
Young Joon Hong, MD, PhD
- Not yet recruiting
Jeju National University Hospital
Jeju City
Ki-Seok Kim, MD, PhD
- Recruiting
Chung-Ang University Hospital
Seoul, 06973
Sang-Wook Kim, MD, PhD
- Not yet recruiting
Korea University Guro Hospital
Seoul
Seung-Woon Rha, MD, PhD
- Not yet recruiting
Ajou University Hospital
Suwon
So-Yeon Choi, MD, PhD
About this study
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)
This study evaluate the effect of dipeptidyl-peptidase 4 inhibitor on vascular healing after biodegradable polymer based sirolimus eluting stent implantation in diabetic pateints.
- Conditions
- Acute Coronary Syndrome, Diabetes Mellitus, Type 2
- Being tested
- Sitagliptin, Non DPP-4 Inhibitor
- Medical subject headings
- Acute Coronary Syndrome, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Janiuvia
Sitagliptin is indicated to control hyperglycemia in type 2 diabetic patients.
Non DPP-4 InhibitorDrug
This group patients is permitted to take any other oral anti-hyperglycemic agents except sitagliptin.
| Study group | Role | What they receive |
|---|---|---|
| DPP-4 Inhibitor | Experimental | Any dose of Sitagliptin for 6 months with any other oral anti-diabetic medication Receives: Drug: Sitagliptin |
| Non DPP-4 Inhibitor | Active comparator | Oral anti-diabetic medication except DPP-4 inhibitor Receives: Drug: Non DPP-4 Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neointimal coverage assessed by optical coherence tomography
Measured: 6 months
Secondary outcomes (2)
Malapposition, neointimal thickness or any optical coherence tomographic finding
Measured: 6 months
Biomarkers
CD 34+ cell, hs CRP ect.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Wook Kim, Chung-Ang University
- Investigators
- Sang-Wook Kim, MD, PhD, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802644
- Sponsor's protocol ID
- CAU001
- Status last verified
- Jun 2016
- First submitted
- 13 Jun 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02802644
- Acronym / sponsor ID
- CAU001
- Conditions
- Acute Coronary Syndrome, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Chung-Ang UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2019 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPP-4 Inhibitor | Experimental | Drug: SitagliptinAny dose of Sitagliptin for 6 months with any other oral anti-diabetic medication |
| Non DPP-4 Inhibitor | Active comparator | Drug: Non DPP-4 InhibitorOral anti-diabetic medication except DPP-4 inhibitor |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-ST segement elevation acute coronary syndrome
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SitagliptinAlso: JaniuviaSitagliptin is indicated to control hyperglycemia in type 2 diabetic patients. | Drug | DPP-4 Inhibitor |
| Non DPP-4 InhibitorThis group patients is permitted to take any other oral anti-hyperglycemic agents except sitagliptin. | Drug | Non DPP-4 Inhibitor |
Primary outcome
Neointimal coverage assessed by optical coherence tomography
Time frame: 6 months
2 secondary outcomes
Malapposition, neointimal thickness or any optical coherence tomographic finding
Time frame: 6 months
Biomarkers
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Wook Kim, MD, PhD principal investigator
Chung-Ang University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sitagliptin and Non DPP-4 Inhibitor in people with Acute Coronary Syndrome and Diabetes Mellitus, Type 2, run by Chung-Ang University at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hoyoun Won, MD, PhD (82-2-6299-2871, nowhy@cau.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neointimal coverage assessed by optical coherence tomography (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.