Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE)
- Conditions
- Coronary Artery Disease
- Interventions
- Drug: Aspirin,Clopidogrel
- Registration Number
- NCT01186146
- Lead Sponsor
- Seung-Jung Park
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5000
-
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aspirin Aspirin monotherapy Aspirin monotherapy (stopping clopidogrel at 1 year after DES) Aspirin,Clopidogrel Aspirin,Clopidogrel Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES)
- Primary Outcome Measures
Name Time Method The composite of cardiac death, myocardial infarction, or stroke at 2 year after randomization
- Secondary Outcome Measures
Name Time Method stroke at 2 year after randomization death at 2 year after randomization myocardial infarction 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 Target Vessl revascularization at 2 year after randomization Target Lesion Revascularization at 2 year after randomization
Trial Locations
- Locations (18)
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon, Korea, Republic of
Busan Saint Mary's Hospital
🇰🇷Busan, Korea, Republic of
Cheongju Saint Mary's Hospital
🇰🇷Cheongju, Korea, Republic of
Chungju ST.Mary's Hospital
🇰🇷Cheongju, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chooncheon, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Catholic University, Kangnam St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Korea Veterans Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
St.Mary's Catholic Medical Center
🇰🇷Seoul, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
NHIC Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
DongGuk University Gyongju Hospital
🇰🇷Gyongju, Korea, Republic of
Hangang Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of