Coronary Artery DiseasePhase 4DES-LATENCT01186146
Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE)
A Phase 4 study testing Aspirin monotherapy and Aspirin,Clopidogrel in people with Coronary Artery Disease, run by Seung-Jung Park at 19 sites in South Korea.
Trial summary
This is randomized-controlled trial to evaluate the difference of composite of cardiac death, myocardial infarction, or Stroke between the dual antiplatelet therapy group and the aspirin monotherapy group after 1-year of drug-eluting stents implantation. 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 monotherapy and Aspirin,Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 19 sitesSouth Korea
- Study dates
- Aug 2010to Oct 2013
- 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
- 1. Patients had undergone DES implantation at least 12 months before enrollment, had not had a MACE (death, MI, stroke, or repeat revascularization) or major bleeding, and were dual-therapy at the time of enrollment.
- 2. Time for index PCI to randomization: 12-18 months
Who cannot join
- Contraindications to the use of antiplatelet drugs (e.g., a concurrent bleeding diathesis or a history of major bleeding)
- Concomitant vascular disease requiring long-term use of clopidogrel
- Other established indications for clopidogrel therapy (e.g., a recent ACS).
- Noncardiac coexisting conditions with a life expectancy < 1 year.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
South Korea19 sites
Soonchunhyang University Bucheon Hospital
Bucheon-si
Busan Saint Mary's Hospital
Busan
Cheongju Saint Mary's Hospital
Cheongju-si
Chungju ST.Mary's Hospital
Cheongju-si
Kangwon National University Hospital
Chooncheon
Daegu Catholic University Medical Center
Daegu
Kyungpook National University Hospital
Daegu
Chungnam National University Hospital
Daejeon
Asan Medical Center
Gangneung
Chonnam National University Hospital
Gwangju
DongGuk University Gyongju Hospital
Gyongju
NHIC Ilsan Hospital
Ilsan
Chonbuk National University Hospital
Jeonju
Asan Medical Center
Seoul
Catholic University, Kangnam St. Mary's Hospital
Seoul
Hangang Sacred Heart Hospital
Seoul
Korea University Guro Hospital
Seoul
Korea Veterans Hospital
Seoul
St.Mary's Catholic Medical Center
Seoul
About this study
Official title: Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events
This is randomized-controlled trial to evaluate the difference of composite of cardiac death, myocardial infarction, or Stroke between the dual antiplatelet therapy group and the aspirin monotherapy group after 1-year of drug-eluting stents implantation.
Read the detailed description
This is subsequent clinical trial of previously published pooled analysis of the REAL-LATE and the ZEST-LATE Trial, in which nonsignificant higher trend for increased rate of death (all-cause and cardiac), myocardial infarction, or stroke in the dual antiplatelet therapy group compared to the aspirin monotherapy group was noted.
- Conditions
- Coronary Artery Disease
- Being tested
- Aspirin monotherapy, Aspirin,Clopidogrel
- Keywords
- coronary disease, stents, antiplatelet drugs, drug-eluting stents
- Medical subject headings
- Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin monotherapyDrug
stopping clopidogrel at 1 year after DES
Aspirin,ClopidogrelDrug
Also called Aspirin,Clopidogrel Dual antiplatelet therapy
continue aspirin and clopidogrel 1year after DES
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Aspirin monotherapy (stopping clopidogrel at 1 year after DES) Receives: Drug: Aspirin monotherapy |
| Aspirin,Clopidogrel | Experimental | 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.
The composite of cardiac death, myocardial infarction, or stroke
Measured: at 2 year after randomization
Secondary outcomes (7)
death
Measured: at 2 year after randomization
myocardial infarction
Measured: at 2 year after randomization
stroke
Measured: at 2 year after randomization
stent thrombosis
Measured: at 2 year after randomization
Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
Measured: at 2 year after randomization
Target Vessl revascularization
Measured: at 2 year after randomization
Target Lesion Revascularization
Measured: at 2 year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2012
- Study completionOct 2013
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
- 5,000 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, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186146
- Sponsor's protocol ID
- 2007-0186
- Acronym
- DES-LATE
- Status last verified
- Mar 2014
- First submitted
- 17 Aug 2010
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee CW, Ahn JM, Park DW, Kang SJ, Lee SW, Kim YH, Park SW, Han S, Lee SG, Seong IW, Rha SW, Jeong MH, Lim DS, Yoon JH, Hur SH, Choi YS, Yang JY, Lee NH, Kim HS, Lee BK, Kim KS, Lee SU, Chae JK, Cheong SS, Suh IW, Park HS, Nah DY, Jeon DS, Seung KB, Lee K, Jang JS, Park SJ. Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: a randomized, controlled trial. Circulation. 2014 Jan 21;129(3):304-12. doi: 10.1161/CIRCULATIONAHA.113.003303. Epub 2013 Oct 4.
PubMed 24097439
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
- Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events
- ClinicalTrials.gov ID
- NCT01186146
- Acronym / sponsor ID
- DES-LATE / 2007-0186
- Conditions
- Coronary Artery Disease
- Keywords
- coronary disease, stents, antiplatelet drugs, drug-eluting stents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Aug 2010 (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.
This is randomized-controlled trial to evaluate the difference of composite of cardiac death, myocardial infarction, or Stroke between the dual antiplatelet therapy group and the aspirin monotherapy group after 1-year of drug-eluting stents implantation.
Detailed description
This is subsequent clinical trial of previously published pooled analysis of the REAL-LATE and the ZEST-LATE Trial, in which nonsignificant higher trend for increased rate of death (all-cause and cardiac), myocardial infarction, or stroke in the dual antiplatelet therapy group compared to the aspirin monotherapy group was noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: Aspirin monotherapyAspirin monotherapy (stopping clopidogrel at 1 year after DES) |
| Aspirin,Clopidogrel | Experimental | 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)
- 1. Patients had undergone DES implantation at least 12 months before enrollment, had not had a MACE (death, MI, stroke, or repeat revascularization) or major bleeding, and were dual-therapy at the time of enrollment.
- 2. Time for index PCI to randomization: 12-18 months
Key exclusion criteria (4 listed)
- Contraindications to the use of antiplatelet drugs (e.g., a concurrent bleeding diathesis or a history of major bleeding)
- Concomitant vascular disease requiring long-term use of clopidogrel
- Other established indications for clopidogrel therapy (e.g., a recent ACS).
- Noncardiac coexisting conditions with a life expectancy < 1 year.
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 |
|---|---|---|
| Aspirin monotherapystopping clopidogrel at 1 year after DES | Drug | Aspirin |
| Aspirin,ClopidogrelAlso: Aspirin,Clopidogrel Dual antiplatelet therapycontinue aspirin and clopidogrel 1year after DES | Drug | Aspirin,Clopidogrel |
Primary outcome
The composite of cardiac death, myocardial infarction, or stroke
Time frame: at 2 year after randomization
7 secondary outcomes
death
Time frame: at 2 year after randomization
myocardial infarction
Time frame: at 2 year after randomization
stroke
Time frame: at 2 year after randomization
stent thrombosis
Time frame: at 2 year after randomization
Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
Time frame: at 2 year after randomization
Target Vessl revascularization
Time frame: at 2 year after randomization
Target Lesion Revascularization
Time frame: at 2 year 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 24097439Lee CW, Ahn JM, Park DW, Kang SJ, Lee SW, Kim YH, Park SW, Han S, Lee SG, Seong IW, Rha SW, Jeong MH, Lim DS, Yoon JH, Hur SH, Choi YS, Yang JY, Lee NH, Kim HS, Lee BK, Kim KS, Lee SU, Chae JK, Cheong SS, Suh IW, Park HS, Nah DY, Jeon DS, Seung KB, Lee K, Jang JS, Park SJ. Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: a randomized, controlled trial. Circulation. 2014 Jan 21;129(3):304-12. doi: 10.1161/CIRCULATIONAHA.113.003303. Epub 2013 Oct 4.
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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
Asan Medical Center
19 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 monotherapy and Aspirin,Clopidogrel in people with Coronary Artery Disease, run by Seung-Jung Park at 19 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 4 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 19 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?
The composite of cardiac death, myocardial infarction, or stroke (time frame: at 2 year after randomization). 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 NCT01186146, 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.