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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Aspirin monotherapy; Drug: Aspirin,Clopidogrel

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.

• Study Type: Interventional
• Enrollment (Actual): 5000
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Soonchunhyang University Bucheon Hospital
  • Busan, Korea, Republic of
    • Busan Saint Mary's Hospital
  • Cheongju, Korea, Republic of
    • Cheongju Saint Mary's Hospital
  • Cheongju, Korea, Republic of
    • Chungju ST.Mary's Hospital
  • Chooncheon, Korea, Republic of
    • Kangwon National University Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital
  • Daejeon, Korea, Republic of
    • Chungnam national university hospital
  • GangNeung, Korea, Republic of
    • Asan Medical Center
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Gyongju, Korea, Republic of
    • DongGuk University Gyongju Hospital
  • Ilsan, Korea, Republic of
    • NHIC Ilsan Hospital
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Hangang Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Catholic University, Kangnam St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Korea Veterans Hospital
  • Seoul, Korea, Republic of
    • St.Mary's Catholic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspirin; Aspirin monotherapy (stopping clopidogrel at 1 year after DES)	Drug: Aspirin monotherapy; stopping clopidogrel at 1 year after DES
Experimental: Aspirin,Clopidogrel; Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES)	Drug: Aspirin,Clopidogrel; continue aspirin and clopidogrel 1year after DES; Other Names: Aspirin,Clopidogrel Dual antiplatelet therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The composite of cardiac death, myocardial infarction, or stroke	at 2 year after randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Target Vessl revascularization	at 2 year after randomization
Target Lesion Revascularization	at 2 year after randomization

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: August 17, 2010
• First Submitted That Met QC Criteria: August 20, 2010
• First Posted (Estimate): August 23, 2010

Study Record Updates

• Last Update Posted (Estimate): March 20, 2014
• Last Update Submitted That Met QC Criteria: March 19, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: coronary disease; stents; drug-eluting stents; antiplatelet drugs
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: 2007-0186