Coronary Artery DiseasePhase 4ESSENCE-DM2NCT01186107
Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients
A Phase 4 study testing Endeavor Resolute stent and Cypher stent in people with Coronary Artery Disease and Diabetes, run by Seung-Jung Park at 11 sites in South Korea.
Trial summary
The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Zotarolimus-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, Diabetes
- What is being tested?
- Endeavor Resolute stent and Cypher stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 11 sitesSouth Korea
- Study dates
- Aug 2010to Jul 2013
- 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
- Patients who are eligible for intracoronary stenting
- 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 Left main disease In-stent restenosis Graft vessels
Show all 13Show fewer
- 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
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do
Soonchunhyang University Bucheon Hospital
Bucheon-si
Soonchunhyang University Cheonan Hospital
Cheonan
Kangwon University Hospital
Chuncheon
Daejeon St Mary's Hospital Catholic University
Daejeon
GangNeung Asan Hospital
Gangneung
Chonbuk National University Hospital
Jeonju
Pusan National University Yangsan Hospital
Pusan
Asan Medical Center
Seoul
Seoul Veterans Hospital
Seoul
Ulsan University Hospital
Ulsan
About this study
Official title: Randomized Comparison of Zotarolimus-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 Zotarolimus-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
Prospective, two arms, single blind, randomized multi-center trial of 380 patients enrolled at 24 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Endeavor Resolute stent vs. b) Cypher select. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.
- Conditions
- Coronary Artery Disease, Diabetes
- Being tested
- Endeavor Resolute stent, Cypher stent
- Keywords
- coronary disease, stent
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endeavor Resolute stentDevice
zotarolimus-eluting stent
Cypher stentDevice
sirolimus-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Endeavor Resolute stent | Experimental | zotarolimus-eluting stent Receives: Device: Endeavor Resolute stent |
| Cypher stent | Active comparator | sirolimus-eluting stent Receives: Device: Cypher stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic in-segment late loss
Measured: 9-month angiographic follow-up
Secondary outcomes (5)
Death (all-cause and cardiac)
Measured: at 12 months
myocardial infarction
Measured: at 12 months
stent thrombosis
Measured: at 12 months
target-lesion revascularization
Measured: at 12 months
target-vessel revascularization
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2012
- Study completionJul 2013
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
- 256 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
- Investigators
- Seung-Jung Park, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186107
- Sponsor's protocol ID
- 2009-0220
- Acronym
- ESSENCE-DM2
- Status last verified
- Jul 2014
- First submitted
- 19 Aug 2010
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus
- ClinicalTrials.gov ID
- NCT01186107
- Acronym / sponsor ID
- ESSENCE-DM2 / 2009-0220
- Conditions
- Coronary Artery Disease, Diabetes
- Keywords
- coronary disease, stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Aug 2010 (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 Zotarolimus-Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.
Detailed description
Prospective, two arms, single blind, randomized multi-center trial of 380 patients enrolled at 24 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Endeavor Resolute stent vs. b) Cypher select. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endeavor Resolute stent | Experimental | Device: Endeavor Resolute stentzotarolimus-eluting stent |
| Cypher stent | Active comparator | Device: Cypher stentsirolimus-eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetic patients with angina and documented ischemia
- Patients who are eligible for intracoronary stenting
- De novo lesion
- Percent diameter stenosis ≥50%
- Reference vessel size ≥ 2.5 mm by visual estimation
Key exclusion criteria (13 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 |
|---|---|---|
| Endeavor Resolute stentzotarolimus-eluting stent | Device | Endeavor Resolute stent |
| Cypher stentsirolimus-eluting stent | Device | Cypher stent |
Primary outcome
Angiographic in-segment late loss
Time frame: 9-month angiographic follow-up
5 secondary outcomes
Death (all-cause and cardiac)
Time frame: at 12 months
myocardial infarction
Time frame: at 12 months
stent thrombosis
Time frame: at 12 months
target-lesion revascularization
Time frame: at 12 months
target-vessel revascularization
Time frame: at 12 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 29 Jul 2014.
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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.
Seung-Jung Park principal investigator
Asan Medical Center
11 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 Endeavor Resolute stent and Cypher stent in people with Coronary Artery Disease and Diabetes, run by Seung-Jung Park at 11 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 5 inclusion and 13 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 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 (time frame: 9-month angiographic follow-up). 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 29 Jul 2014.