Status:
TERMINATED
Zotarolimus-Versus Sirolimus-Versus PacliTaxel-Eluting Stent for Acute Myocardial Infarction Patients
Lead Sponsor:
Seung-Jung Park
Collaborating Sponsors:
Cordis US Corp.
CardioVascular Research Foundation, Korea
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The trial has the following primary objective: To compare the safety and effectiveness of primary acute MI intervention with ABT 578-eluting balloon expandable stent (Medtronic, Minneapolis, MN) vs. ...
Detailed Description
Previous studies have documented that a slow-release polymeric sirolimus-eluting stent (Cypher, Cordis) and paclitaxel-eluting stent (Taxus, Boston Scientific) reduce neointimal formation and result i...
Eligibility Criteria
Inclusion
- The patient must be at least 18 years of age.
- Culprit de novo lesion in a native coronary artery with significant stenosis (\>50% by visual estimate) eligible for stent implantation (no limitation on stent length)
- Prolonged, continuous (≥ 20 min) chest pain despite nitrate and: (1) at least 1mm ST-segment elevation in at least 2 leads or reciprocal ST-segment depression ≥ 2 contiguous precordial leads, or (2) newly developed left bundle branch block
- Symptoms \< 12 hours
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion
- The patient has a known hypersensitivity or contraindication to any of the following medications:
- Heparin
- Aspirin
- Both Clopidogrel and TIclopidine
- Sirolimus, paclitaxel, ABT 578
- Stainless steel and/or
- Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
- Systemic (intravenous) Sirolimus, paclitaxel or ABT-578 use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Fibrinolytic therapy for current MI treatment
- Previous coronary intervention on target vessel
- 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).
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Previously documented LVEF \<30%.
- Evident cardiogenic shock before randomization
- Patients with left main stem stenosis (\>50% by visual estimate)
- Severe calcification or tortuosity
- Multi-vessel disease with non-culprit vessel requiring bypass surgery
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT00422565
Start Date
October 1 2006
End Date
September 1 2008
Last Update
December 7 2022
Active Locations (12)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
2
Daegu Catholic University Medical Center
Daegu, South Korea
3
Chungnam National University Hospital
Daejeon, South Korea
4
Asan Medical Center
Gangneung, South Korea