Status:
COMPLETED
Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE)
Lead Sponsor:
Seung-Jung Park
Collaborating Sponsors:
CardioVascular Research Foundation, Korea
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 g...
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 card...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT01186146
Start Date
August 1 2010
End Date
October 1 2013
Last Update
March 20 2014
Active Locations (19)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
2
Busan Saint Mary's Hospital
Busan, South Korea
3
Cheongju Saint Mary's Hospital
Cheongju-si, South Korea
4
Chungju ST.Mary's Hospital
Cheongju-si, South Korea