Clinical trial NCT01186146: Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE)
Official title: Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: coronary disease
stents
antiplatelet drugs
drug-eluting stents
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2010-08-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: The composite of cardiac death, myocardial infarction, or stroke
timeFrame: at 2 year after randomization
Secondary outcomes:
measure: death
timeFrame: at 2 year after randomization
measure: myocardial infarction
timeFrame: at 2 year after randomization
measure: stroke
timeFrame: at 2 year after randomization
measure: stent thrombosis
timeFrame: at 2 year after randomization
measure: Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
timeFrame: at 2 year after randomization
measure: Target Vessl revascularization
timeFrame: at 2 year after randomization
measure: Target Lesion Revascularization
timeFrame: at 2 year after randomization
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Busan Saint Mary's Hospital
city: Cheongju
country: Korea, Republic of
facility: Cheongju Saint Mary's Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungju ST.Mary's Hospital
city: Chooncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: GangNeung
country: Korea, Republic of
facility: Asan Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyongju
country: Korea, Republic of
facility: DongGuk University Gyongju Hospital
city: Ilsan
country: Korea, Republic of
facility: NHIC Ilsan Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Catholic University, Kangnam St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hangang Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Veterans Hospital
city: Seoul
country: Korea, Republic of
facility: St.Mary's Catholic Medical Center
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.