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Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients (ESSENCE-DM2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01186107
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : July 29, 2014
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diabetes Device: Endeavor Resolute stent Device: Cypher stent Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus
Study Start Date : August 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: Endeavor Resolute stent
zotarolimus-eluting stent
Device: Endeavor Resolute stent
zotarolimus-eluting stent

Active Comparator: Cypher stent
sirolimus-eluting stent
Device: Cypher stent
sirolimus-eluting stent

Primary Outcome Measures :
  1. Angiographic in-segment late loss [ Time Frame: 9-month angiographic follow-up ]

Secondary Outcome Measures :
  1. Death (all-cause and cardiac) [ Time Frame: at 12 months ]
  2. myocardial infarction [ Time Frame: at 12 months ]
  3. stent thrombosis [ Time Frame: at 12 months ]
  4. target-lesion revascularization [ Time Frame: at 12 months ]
  5. target-vessel revascularization [ Time Frame: at 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01186107

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Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Gyeong-gi, Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Soonchunhyang University Cheonan Hospital
Cheonan, Korea, Republic of
Kangwon University Hospital
Chuncheon, Korea, Republic of
Daejeon St Mary's Hospital Catholic University
Daejeon, Korea, Republic of
GangNeung Asan Hospital
GangNeung, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Pusan National University Yangsan Hospital
Pusan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Seoul Veterans Hospital
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
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Principal Investigator: Seung-Jung Park Asan Medical Center

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Responsible Party: Seung-Jung Park, M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine, CardioVascular Research Foundation, Korea Identifier: NCT01186107    
Other Study ID Numbers: 2009-0220
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014
Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
coronary disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs