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

Coronary Artery Disease Clinical Trial

— ZEST-LATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590174
• Other study ID #: 20070043
• Status: Completed
• Phase: Phase 4
• First received: December 31, 2007
• Last updated: March 19, 2014
• Start date: October 2007
• Est. completion date: April 2010

Study information

• Verified date: March 2014
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1175
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Aspirin
stopping clopidogrel at 1 year after DES implantation
• Aspirin,Clopidogrel
continue aspirin and clopidogrel 1year after DES

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Asan Medical Center	GangNeung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	NHIC Ilsan Hospital	Ilsan
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Pusan Natioanal University Hospital	Pusan
Korea, Republic of	Hallym University Sacred Heart Hospital,	PyeongChon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	St.Mary's Catholic Medical Center	Seoul
Korea, Republic of	Yonsei University Medical Center	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Yonsei University Wonju Christian Hospital	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of death or myocardial infarction		at 12 months after randomization (at 24 months after ZEST enrollment)	Yes
Secondary	All Death		at 12 months after randomization	Yes
Secondary	Cardiac death		at 12 months after randomization	Yes
Secondary	Myocardial infarction		at 12 months after randomization	Yes
Secondary	Stroke		at 12 months after randomization	Yes
Secondary	Target vessel revascularization (all and ischemia-driven)		at 12 months after randomization	Yes
Secondary	Target lesion revascularization (all and ischemia-driven)		at 12 months after randomization	Yes
Secondary	Stent thrombosis for the patients		at 12 months after randomization	Yes
Secondary	Bleeding event		at 12 months after randomization	Yes