Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CardioVascular Research Foundation, Korea
• Collaborator: Otsuka Korea
• Treatments: Cilostazol

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