NCT00590174

Clopidogrel Use and Long-term Safety After Drug-Eluting Stents Implantation

Evaluation of the Long-term Safety After Zotarolimus-Eluting Stent, Sirolimus-Eluting Stent, or PacliTaxel-Eluting Stent Implantation for Coronary Lesions - Late Coronary Arterial Thrombotic Events

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,175 (actual)
• Sponsor: Seung-Jung Park · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of ZEST-LATE (Evaluation of the Long-term Safety After Zotarolimus-Eluting Stent, Sirolimus-Eluting Stent, or PacliTaxel-Eluting Stent Implantation for Coronary Lesions - Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between long-term clopidogrel use beyond 1 year and long-term rates of death or MI after DES implantation and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.

Detailed description

Prospective, two arms, open-labeled, randomized multi-center trial of approximately 2,000 patients enrolled at 19 centers in Korea. Among all patients enrolled in the ZEST (Comparison of the Efficacy of Zotarolimus-Eluting Stent versus Sirolimus-Eluting Stent versus PacliTaxel-Eluting Stent for Coronary Lesions) trial, event-free patients who survived the first 12 months without nonfatal MI or repeat revascularization will be randomized to discontinue clopidogrel therapy at 12 months after DES implantation. All patients will be followed for another 12 months.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Aspirin	stopping clopidogrel at 1 year after DES implantation
DRUG	Aspirin,Clopidogrel	continue aspirin and clopidogrel 1year after DES

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2008-01-10
• Last updated: 2014-03-20

Locations

20 sites across 1 country: South Korea