Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE)
DES-LATE
Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events
1 other identifier
interventional
5,000
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Aug 2010
Typical duration for phase_4 coronary-artery-disease
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 17, 2010
CompletedFirst Posted
Study publicly available on registry
August 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedMarch 20, 2014
March 1, 2014
2.3 years
August 17, 2010
March 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The composite of cardiac death, myocardial infarction, or stroke
at 2 year after randomization
Secondary Outcomes (7)
death
at 2 year after randomization
myocardial infarction
at 2 year after randomization
stroke
at 2 year after randomization
stent thrombosis
at 2 year after randomization
Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
at 2 year after randomization
- +2 more secondary outcomes
Study Arms (2)
Aspirin
ACTIVE COMPARATORAspirin monotherapy (stopping clopidogrel at 1 year after DES)
Aspirin,Clopidogrel
EXPERIMENTALAspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES)
Interventions
continue aspirin and clopidogrel 1year after DES
Eligibility Criteria
You may qualify if:
- \. 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.
- \. Time for index PCI to randomization: 12-18 months
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (19)
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Busan Saint Mary's Hospital
Busan, South Korea
Cheongju Saint Mary's Hospital
Cheongju-si, South Korea
Chungju ST.Mary's Hospital
Cheongju-si, South Korea
Kangwon National University Hospital
Chooncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Asan Medical Center
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
DongGuk University Gyongju Hospital
Gyongju, South Korea
NHIC Ilsan Hospital
Ilsan, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Asan Medical Center
Seoul, South Korea
Catholic University, Kangnam St. Mary's Hospital
Seoul, South Korea
Hangang Sacred Heart Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Korea Veterans Hospital
Seoul, South Korea
St.Mary's Catholic Medical Center
Seoul, South Korea
Related Publications (1)
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.
PMID: 24097439DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park, MD, PhD
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
Study Record Dates
First Submitted
August 17, 2010
First Posted
August 23, 2010
Study Start
August 1, 2010
Primary Completion
December 1, 2012
Study Completion
October 1, 2013
Last Updated
March 20, 2014
Record last verified: 2014-03