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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00589927 |
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Date of registration:
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31/12/2007 |
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Primary sponsor: |
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Public title:
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Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent
DECLARELONG |
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Scientific title:
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Comparison of Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent Implantation For Long Coronary Lesions |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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486 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00589927 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Seung-Wook Park, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Clinical 1) Patients with angina and documented ischemia or patients with documented
silent ischemia 2) Patients who are eligible for intracoronary stenting 3) Age >18
years, <75 ages
2. Angiographic 1) De novo lesion 2) Percent diameter stenosis =50% 3) Reference vessel
size >2.5 mm by visual estimation 4) Lesion length >25 mm by visual estimation that
is required for long Endeavor stent implantation (planned total stent length >30mm)
Exclusion Criteria:
1. History of bleeding diathesis or coagulopathy
2. Pregnant
3. Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus and
paclitaxel
4. Limited life-expectancy (less than 1 year) due to combined serious disease
5. ST-elevation acute myocardial infarction
6. Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft
vessels
7. Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)
8. Hepatic dysfunction, liver enzyme (ALT and AST) elevation >3 times normal
9. Renal dysfunction, creatinine >2.0mg/dL
10. Contraindication to aspirin, clopidogrel or cilostazol
11. planned bifurcation stenting
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Intervention(s)
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Drug: cilostazol
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Drug: placebo
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Primary Outcome(s)
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Angiographic in-stent late loss
[Time Frame: 8-months after randomization]
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Secondary Outcome(s)
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Composite of death, MI, and target lesion or vessel revascularization at 12 months, In-stent and in-stent restenosis at 8 months, In-segment late loss at 8 months Adverse side effects during treatment
[Time Frame: 12 months]
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Secondary ID(s)
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2007-0003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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