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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aspirin monotherapy
Aspirin,Clopidogrel
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary disease, stents, antiplatelet drugs, drug-eluting stents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Soonchunhyang University Bucheon Hospital
  • Busan Saint Mary's Hospital
  • Cheongju Saint Mary's Hospital
  • Chungju ST.Mary's Hospital
  • Kangwon National University Hospital
  • Daegu Catholic University Medical Center
  • Kyungpook National University Hospital
  • Chungnam National University Hospital
  • Asan Medical Center
  • Chonnam National University Hospital
  • DongGuk University Gyongju Hospital
  • NHIC Ilsan Hospital
  • Chonbuk National University Hospital
  • Asan Medical Center
  • Catholic University, Kangnam St. Mary's Hospital
  • Hangang Sacred Heart Hospital
  • Korea University Guro Hospital
  • Korea Veterans Hospital
  • St.Mary's Catholic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Aspirin

Aspirin,Clopidogrel

Arm Description

Aspirin monotherapy (stopping clopidogrel at 1 year after DES)

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

Outcomes

Primary Outcome Measures

The composite of cardiac death, myocardial infarction, or stroke

Secondary Outcome Measures

death
myocardial infarction
stroke
stent thrombosis
Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
Target Vessl revascularization
Target Lesion Revascularization

Full Information

First Posted
August 17, 2010
Last Updated
March 19, 2014
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01186146
Brief Title
Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE)
Acronym
DES-LATE
Official Title
Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary disease, stents, antiplatelet drugs, drug-eluting stents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
Aspirin monotherapy (stopping clopidogrel at 1 year after DES)
Arm Title
Aspirin,Clopidogrel
Arm Type
Experimental
Arm Description
Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES)
Intervention Type
Drug
Intervention Name(s)
Aspirin monotherapy
Intervention Description
stopping clopidogrel at 1 year after DES
Intervention Type
Drug
Intervention Name(s)
Aspirin,Clopidogrel
Other Intervention Name(s)
Aspirin,Clopidogrel Dual antiplatelet therapy
Intervention Description
continue aspirin and clopidogrel 1year after DES
Primary Outcome Measure Information:
Title
The composite of cardiac death, myocardial infarction, or stroke
Time Frame
at 2 year after randomization
Secondary Outcome Measure Information:
Title
death
Time Frame
at 2 year after randomization
Title
myocardial infarction
Time Frame
at 2 year after randomization
Title
stroke
Time Frame
at 2 year after randomization
Title
stent thrombosis
Time Frame
at 2 year after randomization
Title
Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
Time Frame
at 2 year after randomization
Title
Target Vessl revascularization
Time Frame
at 2 year after randomization
Title
Target Lesion Revascularization
Time Frame
at 2 year after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jung Park, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Busan Saint Mary's Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Cheongju Saint Mary's Hospital
City
Cheongju
Country
Korea, Republic of
Facility Name
Chungju ST.Mary's Hospital
City
Cheongju
Country
Korea, Republic of
Facility Name
Kangwon National University Hospital
City
Chooncheon
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
GangNeung
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
DongGuk University Gyongju Hospital
City
Gyongju
Country
Korea, Republic of
Facility Name
NHIC Ilsan Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Catholic University, Kangnam St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea Veterans Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
St.Mary's Catholic Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24097439
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.
Results Reference
derived

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

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