Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent (DECLARELONG)
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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.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Drug: cilostazol Drug: placebo |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Official Title: | Comparison of Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent Implantation For Long Coronary Lesions |
- Angiographic in-stent late loss [ Time Frame: 8-months after randomization ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
Estimated Enrollment: | 486 |
Study Start Date: | December 2007 |
Study Completion Date: | February 2010 |
Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: cilostazol
Cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
|
Drug: cilostazol
cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
Other Name: cilostazol
|
Placebo Comparator: placebo
Control placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
|
Drug: placebo
placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
Other Name: placebo
|
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.
![](https://webarchive.library.unt.edu/web/20121019031144im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
![](https://webarchive.library.unt.edu/web/20121019031144im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Korea, Republic of | |
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 | |
Hangang Sacred Heart Hospital | |
Seoul, Korea, Republic of | |
Asan Medical Center | |
Seoul, Korea, Republic of, 138-736 | |
Soonchunhyang University Seoul Hospital | |
Seoul, Korea, Republic of | |
Seoul Veterans Hospital | |
Seoul, Korea, Republic of | |
Ulsan University Hospital | |
Ulsan, Korea, Republic of |
Principal Investigator: | Seung-Wook Park, MD,PhD | Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine |
![](https://webarchive.library.unt.edu/web/20121019031144im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Seong-Wook Park, MD, PhD, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT00589927 History of Changes |
Other Study ID Numbers: | 2007-0003 |
Study First Received: | December 31, 2007 |
Last Updated: | March 17, 2010 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by CardioVascular Research Foundation, Korea:
stents cilostazol |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cilostazol Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
Hematologic Agents Platelet Aggregation Inhibitors Vasodilator Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents Phosphodiesterase 3 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on October 17, 2012