Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent
DECLARELONG
Comparison of Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent Implantation For Long Coronary Lesions
1 other identifier
interventional
486
1 country
10
Brief Summary
To evaluate whether the cilostazol reduce neointimal hyperplasia after ZES (Zotarolimus-eluting stents) implantation, the investigators performed double-blind,randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin plus clopidogrel plus cilostazol) and dual antiplatelet therapy (aspirin plus clopidogrel) for 8 months in patients with long coronary lesion treated with ZES.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 coronary-artery-disease
Started Dec 2007
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 31, 2007
CompletedFirst Posted
Study publicly available on registry
January 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMarch 18, 2010
July 1, 2009
2 years
December 31, 2007
March 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Angiographic in-stent late loss
8-months after randomization
Secondary Outcomes (1)
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
12 months
Study Arms (2)
cilostazol
EXPERIMENTALCilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
placebo
PLACEBO COMPARATORControl placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
Interventions
cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
Eligibility Criteria
You may qualify if:
- 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
- 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)
You may not qualify if:
- History of bleeding diathesis or coagulopathy
- Pregnant
- Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus and paclitaxel
- Limited life-expectancy (less than 1 year) due to combined serious disease
- ST-elevation acute myocardial infarction
- Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) 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
- planned bifurcation stenting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioVascular Research Foundation, Korealead
- Otsuka Koreacollaborator
Study Sites (10)
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Soonchunhyang University Hospital, Cheonan
Cheonan, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Hallym University Sacred Heart Hospital,
Pyeongchon, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hangang Sacred Heart Hospital
Seoul, South Korea
Seoul Veterans Hospital
Seoul, South Korea
Soonchunhyang University Seoul Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Related Publications (1)
Lee SW, Park SW, Kim YH, Yun SC, Park DW, Lee CW, Kang SJ, Park SJ, Lee JH, Choi SW, Seong IW, Lee NH, Cho YH, Shin WY, Lee SJ, Lee SW, Hyon MS, Bang DW, Choi YJ, Kim HS, Lee BK, Lee K, Park HK, Park CB, Lee SG, Kim MK, Park KH, Park WJ; DECLARE-LONG II Study Investigators. A randomized, double-blind, multicenter comparison study of triple antiplatelet therapy with dual antiplatelet therapy to reduce restenosis after drug-eluting stent implantation in long coronary lesions: results from the DECLARE-LONG II (Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients with Long Coronary Lesions) trial. J Am Coll Cardiol. 2011 Mar 15;57(11):1264-70. doi: 10.1016/j.jacc.2010.10.035.
PMID: 21392640DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Wook Park, MD,PhD
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 31, 2007
First Posted
January 10, 2008
Study Start
December 1, 2007
Primary Completion
December 1, 2009
Study Completion
February 1, 2010
Last Updated
March 18, 2010
Record last verified: 2009-07