Coronary Artery DiseasePhase 4ZEST-LATENCT00590174
Clopidogrel Use and Long-term Safety After Drug-Eluting Stents Implantation
A Phase 4 study testing Aspirin and Aspirin,Clopidogrel in people with Coronary Artery Disease, run by Seung-Jung Park at 20 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Aspirin and Aspirin,Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,175 participants
- Where
- 20 sitesSouth Korea
- Study dates
- Oct 2007to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
South Korea20 sites
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
Kyungpook National University Hospital
Daegu
Chungnam National University Hospital
Daejeon
Asan Medical Center
Gangneung
Chonnam National University Hospital
Gwangju
NHIC Ilsan Hospital
Ilsan
Chonbuk National University Hospital
Jeonju
Pusan Natioanal University Hospital
Pusan
Hallym University Sacred Heart Hospital,
Pyeongchon
Seoul National University Bundang Hospital
Seongnam
Asan Medical Center
Seoul, 138-736
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
St.Mary's Catholic Medical Center
Seoul
Yonsei University Medical Center
Seoul
Ajou University Hospital
Suwon
Ulsan University Hospital
Ulsan
Yonsei University Wonju Christian Hospital
Wŏnju
About this 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
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.
Read the 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
- Being tested
- Aspirin, Aspirin,Clopidogrel
- Keywords
- stent, antiplatelet therapy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Aspirin monotherapy
stopping clopidogrel at 1 year after DES implantation
Aspirin,ClopidogrelDrug
Also called Aspirin,Clopidogrel Dual antiplatelet therapy
continue aspirin and clopidogrel 1year after DES
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | Aspirin monotherapy (stopping clopidogrel at 1 year after DES) Receives: Drug: Aspirin |
| Aspirin,Clopidogrel | Active comparator | Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES) Receives: Drug: Aspirin,Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of death or myocardial infarction
Measured: at 12 months after randomization (at 24 months after ZEST enrollment)
Secondary outcomes (8)
All Death
Measured: at 12 months after randomization
Cardiac death
Measured: at 12 months after randomization
Myocardial infarction
Measured: at 12 months after randomization
Stroke
Measured: at 12 months after randomization
Target vessel revascularization (all and ischemia-driven)
Measured: at 12 months after randomization
Target lesion revascularization (all and ischemia-driven)
Measured: at 12 months after randomization
Stent thrombosis for the patients
Measured: at 12 months after randomization
Bleeding event
Measured: at 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, CardioVascular Research Foundation, Korea
- Investigators
- Seung-Jung Park, MD, PhD, Principal investigator, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590174
- Sponsor's protocol ID
- 20070043
- Acronym
- ZEST-LATE
- Status last verified
- Mar 2014
- First submitted
- 31 Dec 2007
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park SJ, Park DW, Kim YH, Kang SJ, Lee SW, Lee CW, Han KH, Park SW, Yun SC, Lee SG, Rha SW, Seong IW, Jeong MH, Hur SH, Lee NH, Yoon J, Yang JY, Lee BK, Choi YJ, Chung WS, Lim DS, Cheong SS, Kim KS, Chae JK, Nah DY, Jeon DS, Seung KB, Jang JS, Park HS, Lee K. Duration of dual antiplatelet therapy after implantation of drug-eluting stents. N Engl J Med. 2010 Apr 15;362(15):1374-82. doi: 10.1056/NEJMoa1001266. Epub 2010 Mar 15.
PubMed 20231231
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00590174
- Acronym / sponsor ID
- ZEST-LATE / 20070043
- Conditions
- Coronary Artery Disease
- Keywords
- stent, antiplatelet therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,175 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Oct 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: AspirinAspirin monotherapy (stopping clopidogrel at 1 year after DES) |
| Aspirin,Clopidogrel | Active comparator | Drug: Aspirin,ClopidogrelAspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAlso: Aspirin monotherapystopping clopidogrel at 1 year after DES implantation | Drug | Aspirin |
| Aspirin,ClopidogrelAlso: Aspirin,Clopidogrel Dual antiplatelet therapycontinue aspirin and clopidogrel 1year after DES | Drug | Aspirin,Clopidogrel |
Primary outcome
Composite of death or myocardial infarction
Time frame: at 12 months after randomization (at 24 months after ZEST enrollment)
8 secondary outcomes
All Death
Time frame: at 12 months after randomization
Cardiac death
Time frame: at 12 months after randomization
Myocardial infarction
Time frame: at 12 months after randomization
Stroke
Time frame: at 12 months after randomization
Target vessel revascularization (all and ischemia-driven)
Time frame: at 12 months after randomization
Target lesion revascularization (all and ischemia-driven)
Time frame: at 12 months after randomization
Stent thrombosis for the patients
Time frame: at 12 months after randomization
Bleeding event
Time frame: at 12 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
- Derived from this study: PubMed 20231231Park SJ, Park DW, Kim YH, Kang SJ, Lee SW, Lee CW, Han KH, Park SW, Yun SC, Lee SG, Rha SW, Seong IW, Jeong MH, Hur SH, Lee NH, Yoon J, Yang JY, Lee BK, Choi YJ, Chung WS, Lim DS, Cheong SS, Kim KS, Chae JK, Nah DY, Jeon DS, Seung KB, Jang JS, Park HS, Lee K. Duration of dual antiplatelet therapy after implantation of drug-eluting stents. N Engl J Med. 2010 Apr 15;362(15):1374-82. doi: 10.1056/NEJMoa1001266. Epub 2010 Mar 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Jung Park, MD, PhD principal investigator
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and Aspirin,Clopidogrel in people with Coronary Artery Disease, run by Seung-Jung Park at 20 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of death or myocardial infarction (time frame: at 12 months after randomization (at 24 months after ZEST enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00590174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.