Coronary Artery Disease
Conditions
Keywords
stent, antiplatelet therapy
Brief 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.
Interventions
DRUGAspirin
stopping clopidogrel at 1 year after DES implantation
continue aspirin and clopidogrel 1year after DES
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Among the participants in the ZEST trial, event-free patients who survived the first 12 months without nonfatal MI or repeat revascularization 2. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
1. Contraindication to antiplatelet therapy 2. Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment). 3. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 4. Bleeding diathesis 5. Recent stroke within 6-months 6. Concurrent organ damage (creatinine level \> 2.0mg/dL or AST and ALT \> 3 times upper normal reference values) 7. Patients with left main stem stenosis (\>50% by visual estimate)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of death or myocardial infarction | at 12 months after randomization (at 24 months after ZEST enrollment) |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac death | at 12 months after randomization |
| Myocardial infarction | at 12 months after randomization |
| Stroke | at 12 months after randomization |
| All Death | at 12 months after randomization |
| Target lesion revascularization (all and ischemia-driven) | at 12 months after randomization |
| Stent thrombosis for the patients | at 12 months after randomization |
| Bleeding event | at 12 months after randomization |
| Target vessel revascularization (all and ischemia-driven) | at 12 months after randomization |
Countries
South Korea
Outcome results
None listed