Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent

Condition(s) targeted: Coronary Artery Disease

Intervention: cilostazol (Drug); placebo (Drug)

Phase: Phase 4

Status: Recruiting

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

Overall contact:
Seong-Wook Park, MD, PhD, Phone: 2-3010-3153, Ext: 82, Email: swpark@amc.seoul.kr

To evaluate whether the cilostazol reduce neointimal hyperplasia after ZES (Zotarolimus-eluting stents) implantation, we 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.

Official title: Comparison of Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent Implantation For Long Coronary Lesions

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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, We 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.

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

Seong-Wook Park, MD, PhD, Phone: 2-3010-3153, Ext: 82, Email: swpark@amc.seoul.kr

Asan Medical Center, Seoul 138-736, Korea, Republic of; Recruiting
Seong-Wook Park, MD, PhD, Phone: 2-3010-3153, Ext: 82, Email: swpark@amc.seoul.kr
Seung-Whan Lee, MD, PhD, Phone: 2-3010-3170, Ext: 82, Email: seungwlee@amc.seoul.kr
Seong-Wook Park, DM, PhD, Principal Investigator

Chungnam National University Hospital, Daejeon, Korea, Republic of; Recruiting
In-Whan Seong, MD, PhD
In-Whan Seong, MD, PhD, Principal Investigator

Hangang Sacred Heart Hospital, Seoul, Korea, Republic of; Recruiting
Min-Gyu Kim, MD
Min-Gyu Kim, MD, Principal Investigator

Kangwon National University Hospital, Chuncheon, Korea, Republic of; Recruiting
Bong-Ki Lee, MD, PhD
Bong-Ki Lee, MD, PhD, Principal Investigator

Seoul Veterans Hospital, Seoul, Korea, Republic of; Recruiting
Keun Lee, MD, PhD
Keun Lee, MD, PhD, Principal Investigator

Ulsan University Hospital, Ulsan, Korea, Republic of; Recruiting
Sang-Gon Lee, MD, PhD
Sang-Gon Lee, MD, PhD, Principal Investigator

Hallym University Sacred Heart Hospital,, PyeongChon, Korea, Republic of; Recruiting
Young-Jin Choi, MD, PhD
Young-Jin Choi, MD, PhD, Principal Investigator

Soonchunhyang University Bucheon Hospital, Bucheon, Korea, Republic of; Recruiting
Nae-Hee Lee, MD, PhD
Nae-Hee Lee, MD, PhD, Principal Investigator

Soonchunhyang University Seoul Hospital, Seoul, Korea, Republic of; Recruiting
Min-Su Hyun, MD, PhD
Min-Su Hyun, MD, PhD, Principal Investigator

Soonchunhyang University Hospital, Cheonan, Cheonan, Korea, Republic of; Recruiting
Dong-Gyu Jin, MD, PhD
Dong-Gyu Jin, MD, PhD, Principal Investigator

Starting date: December 2007
Ending date: December 2009
Last updated: July 30, 2009