Coronary Artery DiseasePhase 4ESSENCE-DMNCT00997763
Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus
A Phase 4 study testing XIENCE V and CYPHER in people with Coronary Artery Disease, run by Seung-Jung Park at 18 sites in South Korea.
Trial summary
The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Everolimus- Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- XIENCE V and CYPHER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 18 sitesSouth Korea
- Study dates
- Jul 2008to Aug 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic patients with angina and documented ischemia or patients with documented silent ischemia
- Patients who are eligible for intracoronary stenting
- Age >18 years, <75 ages
- De novo lesion
- Percent diameter stenosis ≥50%
- Reference vessel size ≥ 2.5 mm by visual estimation
Who cannot join
- History of bleeding diathesis or coagulopathy
- Pregnant state
- Known hypersensitivity or contra-indication to contrast agent and heparin
- Limited life-expectancy (less than 1 year)
- Acute ST elevation myocardial infarction on admission
- Characteristics of lesion
Show all 16Show fewer
- Left main disease
- In-stent restenosis
- Graft vessels
- Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)
- Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal
- Renal dysfunction, creatinine ≥ 2.0mg/dL
- Contraindication to aspirin, clopidogrel or cilostazol
- Left ventricular ejection fraction <30%
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
Soonchunhyang University Bucheon Hospital
Bucheon-si
Busan Saint Mary's Hospital
Busan
Soonchunhyang University Cheonan Hospital
Cheonan
Cheongju Saint Mary's Hospital
Cheongju-si
Kangwon University Hospital
Chuncheon
Chungnam National University Hospital
Daejeon
Daejeon St Mary's Hospital Catholic University
Daejeon
Asan Medical Center
Gangneung
Chonbuk National University Hospital
Jeonju
Kyungsang University Hospital
Jinju
Inje University Pusan Paik Hospital
Pusan
Pusan Natioanal University Hospital
Pusan
Hallym University Sacred Heart Hospital
Pyeongchon
Asan Medical Center
Seoul
Hallym University Sacred Heart Hospital
Seoul
Korea Veterans Hospital
Seoul
Soonchunhyang University Seoul Hospital
Seoul
Ulsan University Hospital
Ulsan
About this study
Official title: Randomized Comparison of Everolimus- Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus
The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Everolimus- Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.
Read the detailed description
Diabetic patients often present unfavorable coronary anatomy with small and diffusely diseased vessels (1) and exhibit exaggerated neointimal hyperplasia after bare-metal stent (BMS) implantation as compared with nondiabetics (2). Although drug-eluting stent (DES) implantation significantly reduced the neointimal hyperplasia and angiographic restenosis compared to BMS in diabetic patients (3), presence of diabetes mellitus (DM) have been still associated with an increased risk of restenosis and unfavorable clinical outcomes in the era of DES (4,5). Recently, the relative efficacies of sirolimua-eluting stent (SES) and paclitaxel-eluting stent (PES) in patients with DM have been evaluated in randomized and registry studies (6-10). The present study, ESSENCE-DIABETES Study, compare 8-month angiographic and 1-year clinical outcomes in patients with diabetes mellitus treated with sirolimus-eluting stent (CYPHER) or everolimus-eluting stent (XIENCE V)
- Conditions
- Coronary Artery Disease
- Being tested
- XIENCE V, CYPHER
- Keywords
- stenting, XIENCE V, CYPHER
- Medical subject headings
- Coronary Artery Disease, Cardiomyopathy, Dilated, 1C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE VDevice
Also called Xience V stent
everolimus-eluting stent
CYPHERDevice
Also called Cypher elect stent
sirolimus-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| XIENCE V | Active comparator | everolimus-eluting stent Receives: Device: XIENCE V |
| CYPHER | Active comparator | Using Cypher stent Receives: Device: CYPHER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic in-segment late loss at angiography
Measured: 8-month
Secondary outcomes (12)
All-cause Death
Measured: 12 month
All-cause Death
Measured: 5 year
Cardiac death
Measured: 12 months
Cardiac death
Measured: 5 year
Myocardial infarction
Measured: 12 months
Myocardial infarction
Measured: 5 year
Target vessel revascularization (all and ischemia-driven)
Measured: 12 months
Target lesion revascularization (all and ischemia-driven)
Measured: 5 year
Stent thrombosis by definition of Academic Research Consortium (ARC)
Measured: 12 months
Stent thrombosis by definition of Academic Research Consortium (ARC)
Measured: 5 year
Binary restenosis in both in-stent and in-segment
Measured: 8 months
Angiographic pattern of restenosis
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startJul 2008
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, CardioVascular Research Foundation, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997763
- Sponsor's protocol ID
- 2008-0220
- Acronym
- ESSENCE-DM
- Status last verified
- Dec 2016
- First submitted
- 18 Oct 2009
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is not a publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Everolimus- Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus
- ClinicalTrials.gov ID
- NCT00997763
- Acronym / sponsor ID
- ESSENCE-DM / 2008-0220
- Conditions
- Coronary Artery Disease
- Keywords
- stenting, XIENCE V, CYPHER
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Jul 2008
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 Oct 2009 (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.
The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Everolimus- Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.
Detailed description
Diabetic patients often present unfavorable coronary anatomy with small and diffusely diseased vessels (1) and exhibit exaggerated neointimal hyperplasia after bare-metal stent (BMS) implantation as compared with nondiabetics (2). Although drug-eluting stent (DES) implantation significantly reduced the neointimal hyperplasia and angiographic restenosis compared to BMS in diabetic patients (3), presence of diabetes mellitus (DM) have been still associated with an increased risk of restenosis and unfavorable clinical outcomes in the era of DES (4,5). Recently, the relative efficacies of sirolimua-eluting stent (SES) and paclitaxel-eluting stent (PES) in patients with DM have been evaluated in randomized and registry studies (6-10). The present study, ESSENCE-DIABETES Study, compare 8-month angiographic and 1-year clinical outcomes in patients with diabetes mellitus treated with sirolimus-eluting stent (CYPHER) or everolimus-eluting stent (XIENCE V)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XIENCE V | Active comparator | Device: XIENCE Veverolimus-eluting stent |
| CYPHER | Active comparator | Device: CYPHERUsing Cypher stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diabetic patients with angina and documented ischemia or patients with documented silent ischemia
- Patients who are eligible for intracoronary stenting
- Age >18 years, <75 ages
- De novo lesion
- Percent diameter stenosis ≥50%
Key exclusion criteria (16 listed)
- History of bleeding diathesis or coagulopathy
- Pregnant state
- Known hypersensitivity or contra-indication to contrast agent and heparin
- Limited life-expectancy (less than 1 year)
- Acute ST elevation myocardial infarction on admission
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 |
|---|---|---|
| XIENCE VAlso: Xience V stenteverolimus-eluting stent | Device | XIENCE V |
| CYPHERAlso: Cypher elect stentsirolimus-eluting stent | Device | CYPHER |
Primary outcome
Angiographic in-segment late loss at angiography
Time frame: 8-month
12 secondary outcomes
All-cause Death
Time frame: 12 month
All-cause Death
Time frame: 5 year
Cardiac death
Time frame: 12 months
Cardiac death
Time frame: 5 year
Myocardial infarction
Time frame: 12 months
Myocardial infarction
Time frame: 5 year
Target vessel revascularization (all and ischemia-driven)
Time frame: 12 months
Target lesion revascularization (all and ischemia-driven)
Time frame: 5 year
Stent thrombosis by definition of Academic Research Consortium (ARC)
Time frame: 12 months
Stent thrombosis by definition of Academic Research Consortium (ARC)
Time frame: 5 year
Binary restenosis in both in-stent and in-segment
Time frame: 8 months
Angiographic pattern of restenosis
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 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 XIENCE V and CYPHER in people with Coronary Artery Disease, run by Seung-Jung Park at 18 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 6 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: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiographic in-segment late loss at angiography (time frame: 8-month). 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 13 Dec 2016.