Clinical trial NCT01186107: Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Diabetes
Keywords: coronary disease
stent
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2010-08-23
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Angiographic in-segment late loss
timeFrame: 9-month angiographic follow-up
Secondary outcomes:
measure: Death (all-cause and cardiac)
timeFrame: at 12 months
measure: myocardial infarction
timeFrame: at 12 months
measure: stent thrombosis
timeFrame: at 12 months
measure: target-lesion revascularization
timeFrame: at 12 months
measure: target-vessel revascularization
timeFrame: at 12 months
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeong-gi
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Cheonan Hospital
city: Chuncheon
country: Korea, Republic of
facility: Kangwon University Hospital
city: Daejeon
country: Korea, Republic of
facility: Daejeon St Mary's Hospital Catholic University
city: GangNeung
country: Korea, Republic of
facility: GangNeung Asan Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Veterans Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park
role: PRINCIPAL_INVESTIGATOR
References: