Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE)

NCT ID: NCT01186146

Last Updated: 2014-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-10-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aspirin

Aspirin monotherapy (stopping clopidogrel at 1 year after DES)

Group Type: ACTIVE_COMPARATOR

Aspirin monotherapy

Intervention Type: DRUG

stopping clopidogrel at 1 year after DES

Aspirin,Clopidogrel

Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES)

Group Type: EXPERIMENTAL

Aspirin,Clopidogrel

Intervention Type: DRUG

continue aspirin and clopidogrel 1year after DES

Interventions

Aspirin monotherapy

stopping clopidogrel at 1 year after DES

Intervention Type: DRUG

Aspirin,Clopidogrel

continue aspirin and clopidogrel 1year after DES

Intervention Type: DRUG

Other Intervention Names

Aspirin,Clopidogrel Dual antiplatelet therapy

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

Seung-Jung Park

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Seung-Jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 24097439 (View on PubMed)

Other Identifiers

2007-0186

Identifier Type: -

Identifier Source: org_study_id