Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent
Information source: CardioVascular Research Foundation, Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: cilostazol (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: CardioVascular Research Foundation, Korea Official(s) and/or principal investigator(s): Seung-Wook Park, MD,PhD, Principal Investigator, Affiliation: Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
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.
Clinical Details
Official title: Comparison of Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent Implantation For Long Coronary Lesions
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Angiographic in-stent late loss
Secondary outcome: 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
Detailed description:
Use of drug-eluting stent (DES) has reduced the incidence of restenosis rate and the need
for repeat revascularization compared to using bare metal stents. DES implantation also
significantly reduced the angiographic restenosis in patients with long coronary
lesions. However, although the use of DES has decreased the effect of lesion length on
restenosis, the restenosis after DES implantation of long coronary lesions remain at a
higher risk of restenosis.
Cilostazol, a phosphodiesterase III inhibitor, has been known to reduce smooth muscle
proliferation and intimal hyperplasia after endothelial injury and restenosis after balloon
angioplasty and bare-metal stent (BMS) implantation when compared with aspirin and
clopidogrel or ticlopidine. Recently, the impact of 6-month cilostazol treatment in
addition to aspirin and clopidogrel on neointimal hyperplasia after sirolimus-(SES) or
paclitaxel-eluting stent (PES) implantation for long-coronary lesions has been evaluated in
our institution. It reported that cilostazol treatment achieved primary end point (in-stent
late loss) and reduced need of target lesion revascularization without significant adverse
drug-side effects with open-label design, which suggest that 6-month treatment of cilostazol
effectively inhibits the neointimal hyperplasia after DES implantation and can be safely
applied to the patients or lesions with higher risk of restenosis such as diabetes and long
lesions. However, our study was done in unblinded manner and might underestimate the
angiographic results due to relatively short-term follow-up angiographic follow-up(6-month.
Recently commercially available new-DES, zotarolimus-eluting stent (ZES) demonstrated
significant reduction of restenosis and cardiac events during 9-month. However, it has not
been tested that 8-month treatment of cilostazol also effectively inhibits the neointimal
hyperplasia after ZES implantation in patients with long coronary lesions. Therefore, to
evaluate whether the cilostazol reduce neointimal hyperplasia after ZES 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Soonchunhyang University Bucheon Hospital, Bucheon, Korea, Republic of
Soonchunhyang University Hospital, Cheonan, Cheonan, Korea, Republic of
Kangwon National University Hospital, Chuncheon, Korea, Republic of
Chungnam National University Hospital, Daejeon, Korea, Republic of
Hallym University Sacred Heart Hospital,, PyeongChon, Korea, Republic of
Asan Medical Center, Seoul 138-736, Korea, Republic of
Hangang Sacred Heart Hospital, Seoul, Korea, Republic of
Seoul Veterans Hospital, Seoul, Korea, Republic of
Soonchunhyang University Seoul Hospital, Seoul, Korea, Republic of
Ulsan University Hospital, Ulsan, Korea, Republic of
Additional Information
Starting date: December 2007
Last updated: March 17, 2010
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