Clopidogrel Use and Long-Term Safety After Drug-Eluting Stents Implantation - Full Text View

Sponsored by:	CardioVascular Research Foundation, Korea
Information provided by:	CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:	NCT00590174

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Other: Stopping clopidogrel	Phase IV

MedlinePlus related topics: Coronary Artery Disease Heart Attack

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:

Composite of death or myocardial infarction [ Time Frame: at 12 months after randomization (at 24 months after ZEST enrollment) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

All Death [ Time Frame: at 12 months after randomization ] [ Designated as safety issue: Yes ]
Cardiac death [ Time Frame: at 12 months after randomization ] [ Designated as safety issue: Yes ]
Myocardial infarction [ Time Frame: at 12 months after randomization ] [ Designated as safety issue: Yes ]
Stroke [ Time Frame: at 12 months after randomization ] [ Designated as safety issue: Yes ]
Target vessel revascularization (all and ischemia-driven) [ Time Frame: at 12 months after randomization ] [ Designated as safety issue: Yes ]
Target lesion revascularization (all and ischemia-driven) [ Time Frame: at 12 months after randomization ] [ Designated as safety issue: Yes ]
Stent thrombosis for the patients [ Time Frame: at 12 months after randomization ] [ Designated as safety issue: Yes ]
Bleeding eve [ Time Frame: at 12 months after randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	2000
Study Start Date:	October 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental Aspirin monotherapy (clopidogrel stopping at 1 year after DES)	Other: Stopping clopidogrel stopping clopidogrel at 1 year after DES implantation (ZEST-enrolled patients)
A2: Active Comparator Dual antiplatelet therapy (aspirin and clopidogrel)	Other: Stopping clopidogrel stopping clopidogrel at 1 year after DES implantation (ZEST-enrolled patients)

Detailed Description:

Instructions for the use of drug-eluting stents (DES)commercially available in the worldwide specify treatment with clopidogrel for at least 3 months (for sirolimus-coated stents) or 6 months (for paclitaxel-coated stents) after implantation. Premature discontinuation of this minimum antiplatelet therapy has been associated with stent thrombosis. However, studies of late thrombosis events among patients with a drug-eluting stent have cast doubt on whether the recommended regimens are sufficient. An observational analysis from BASKET-LATE (Basel Stent Kosten-Effekivitats Trial-Late Thrombotic Events) examined the incidence of clinical events after cessation of clopidogrel therapy. This study identified 746 patients who were without major adverse events 6 months after drug-eluting or bare-metal stent placement. All patients had stopped taking clopidogrel and were followed up for an additional 12 months. At 18-month follow-up, there was no difference between patients with a drug-eluting or bare-metal stent in cumulative rates of death or myocardial infarction (MI). However, after clopidogrel discontinuation patients receiving drug-eluting vs bare-metal stents experienced higher rates of death and MI (4.9% vs 1.3%, respectively). These results have created uncertainty regarding the minimal necessary duration of antiplatelet therapy after drug-eluting stent implantation. Also, there remains widespread uncertainty regarding the risk of clinical events after the discontinuation of clopidogrel, particularly after DES implantation. Therefore, this study is designed to evaluate the relationship between clopidogrel use and long-term rates of cardiac death or MI after DES implantation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Among the participants in the ZEST trial, event-free patients who survived the first 12 months without nonfatal MI or repeat revascularization
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:

Contraindication to antiplatelet therapy
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).
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Bleeding diathesis
Recent stroke within 6-months
Concurrent organ damage (creatinine level > 2.0mg/dL or AST and ALT > 3 times upper normal reference values)
Patients with left main stem stenosis (>50% by visual estimate)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590174

Contacts

Contact: Seung-Jung Park	2-3010-4812 ext 82	sjpark@amc.seoul.kr
Contact: Duk-Woo Park	2-3010-3995 ext 82	dwpark@amc.seoul.kr

Locations

Korea, Republic of
Ajou University Hospital	Recruiting
Suwon, Korea, Republic of
Contact: Seung-Jae Tahk, MD, PhD
Principal Investigator: Seung-Jae Tahk, MD,PhD
Asan Medical Center	Recruiting
GangNeung, Korea, Republic of
Contact: Sang-Sig Cheong, MD, PhD
Principal Investigator: Sang-Sig Cheong, MD, PhD
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Seung-Jung Park, MD, PhD (82-2)-3010-4812 sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD (82-2)-3010-3995 dwpark@amc.seoul.kr
Principal Investigator: Seung-Jung Park, MD, PhD
Chonbuk National University Hospital	Recruiting
Jeonju, Korea, Republic of
Contact: Jae-Ki Ko, MD, PhD
Principal Investigator: Jae-Ki Ko, MD, PhD
Chonnam National University Hospital	Recruiting
Gwangju, Korea, Republic of
Contact: Myung Ho Jung, MD, PhD
Principal Investigator: Myung Ho Jeong, MD, PhD
Chungnam National University Hospital	Recruiting
Daejeon, Korea, Republic of
Contact: In-Whan Seong, MD, PhD
Principal Investigator: In-Whan Seong, MD, PhD
Daegu Catholic University Medical Center	Recruiting
Daegu, Korea, Republic of
Contact: Kee-Sik Kim, MD, PhD
Principal Investigator: Kee-Sik Kim, MD, PhD
Hallym University Sacred Heart Hospital,	Recruiting
PyeongChon, Korea, Republic of
Contact: Young-Jin Choi, MD, PhD
Principal Investigator: Young-Jin Choi, MD, PhD
Keimyung University Dongsan Medical Center	Recruiting
Daegu, Korea, Republic of
Contact: Seung-Ho Hur, MD, PhD
Principal Investigator: Seung-Ho Hur, MD, PhD
Korea University Anam Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Do-Sun Lim, MD, PhD
Yonsei University Wonju Christian Hospital	Recruiting
Wonju, Korea, Republic of
Contact: Junghan Yoon, MD, PhD
Principal Investigator: Junghan Yoon, MD, PhD
NHIC Ilsan Hospital	Recruiting
Ilsan, Korea, Republic of
Contact: Joo-Young Yang, MD, PhD
Principal Investigator: Joo-Young Yang, MD, PhD
Pusan Natioanal University Hospital	Recruiting
Pusan, Korea, Republic of
Contact: Taeg Jong Hong, MD, PhD
Principal Investigator: Taeg Jong Hong, MD, PhD
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of
Contact: Hyun-Cheol Gwon, MD, PhD
Principal Investigator: Hyun-Cheol Gwon, MD, PhD
Seoul National University Bundang Hospital	Recruiting
Seongnam, Korea, Republic of
Contact: In-Ho Chae
Principal Investigator: In-Ho Chae, MD, PhD
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Hyo-Soo Kim, MD, PhD
Principal Investigator: Hyo-Soo Kim, MD, PhD
St.Mary's Catholic Medical Center	Recruiting
Seoul, Korea, Republic of
Contact: Ki Bae Seung, MD, PhD
Principal Investigator: Ki Bae Seung, MD, PhD
Ulsan University Hospital	Recruiting
Ulsan, Korea, Republic of
Contact: Sang-Gon Lee, MD, PhD
Principal Investigator: Sang-Gon Lee, MD, PhD
Yonsei University Medical Center	Recruiting
Seoul, Korea, Republic of
Contact: YangSoo Jang, MD, PhD
Principal Investigator: YangSoo Jang, MD, PhD
Kyungpook National University Hospital	Recruiting
Daegu, Korea, Republic of
Contact: Hun Sik Park, MD, PhD
Principal Investigator: Hun Sik Park, MD, PhD

Sponsors and Collaborators

CardioVascular Research Foundation, Korea

Investigators

Principal Investigator:

Seung-Jung Park, MD, PhD

Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

More Information

No publications provided

Responsible Party:	CardioVascular Research Foundation ( Seung-Jung Park, MD, PhD )
Study ID Numbers:	20070043
Study First Received:	December 31, 2007
Last Updated:	January 9, 2008
ClinicalTrials.gov Identifier:	NCT00590174 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:

stent
antiplatelet therapy

Study placed in the following topic categories:

Sirolimus
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Paclitaxel
Clopidogrel

Myocardial Ischemia
Vascular Diseases
Platelet Aggregation Inhibitors
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Arteriosclerosis
Pharmacologic Actions

Coronary Disease
Clopidogrel
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009