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Association of Clopidogrel Therapy and Stent Thrombosis (REAL-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. Among consecutive patients treated with DES, event-free patients who survived at least the first 12 months without nonfatal MI or repeat revascularization
  2. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

  1. Contraindication to antiplatelet therapy (aspirin or clopidogrel)
  2. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  3. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  4. Concurrent bleeding diathesis or major bleeding history requiring discontinuation of antiplatelet drugs.
  5. Patients with left main stem stenosis (>50% by visual estimate) or left main stenting
  6. Concomitant disease requiring long-term use of clopidogrel (stroke, peripheral vascular disease, significant carotid a. disease, etc)

Sites / Locations

  • Soonchunhyang University Bucheon Hospital
  • Choeng Ju St.Mary's Hospital
  • Kangwon National University Hospital
  • Chungnam National University Hospital
  • Asan Medical Center
  • DongGuk University Gyongju Hospital
  • Chonbuk National University Hospital
  • Kwangju Christian Hospital
  • Asan Medical Center
  • Hangang Sacred Heart Hospital
  • Kyungsang University Hospital
  • Seoul Veterans Hospital
  • Ulsan University Hospital

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 or MI in the intent-to-treat population

Secondary Outcome Measures

All death
Myocardial infarction
Stroke
Stent Thrombosis
Bleeding events

Full Information

First Posted
June 11, 2007
Last Updated
August 9, 2012
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00484926
Brief Title
Association of Clopidogrel Therapy and Stent Thrombosis
Acronym
REAL-LATE
Official Title
Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated With Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (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
The purpose of REAL-LATE (Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated with Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between clopidogrel use and long-term rates of cardiac death or MI after DES implantation in real-world practice and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.
Detailed Description
An observational analysis from BASKET-LATE (Basel Stent Kosten-Effekivitats Trial-Late Thrombotic Events) examined the incidence of clinical events after cessation of clopidogrel therapy. This study identified 746 patients who were without major adverse events 6 months after drug-eluting or bare-metal stent placement. All patients had stopped taking clopidogrel and were followed up for an additional 12 months. At 18-month follow-up, there was no difference between patients with a drug-eluting or bare-metal stent in cumulative rates of death or myocardial infarction (MI). However, after clopidogrel discontinuation patients receiving drug-eluting vs bare-metal stents experienced higher rates of death and MI (4.9% vs 1.3%, respectively). These results have created uncertainty regarding the minimal necessary duration of antiplatelet therapy after drug-eluting stent implantation. Also, there remains widespread uncertainty regarding the risk of clinical events after the discontinuation of clopidogrel, particularly after DES implantation.

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
2000 (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 or MI in the intent-to-treat population
Time Frame
1 year after randomization
Secondary Outcome Measure Information:
Title
All death
Time Frame
1 year after randomization
Title
Myocardial infarction
Time Frame
1 year after randomization
Title
Stroke
Time Frame
1 year after randomization
Title
Stent Thrombosis
Time Frame
1 year after randomization
Title
Bleeding events
Time Frame
1 year after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Among consecutive patients treated with DES, event-free patients who survived at least the first 12 months without nonfatal MI or repeat revascularization The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: Contraindication to antiplatelet therapy (aspirin or clopidogrel) Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment). Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. Concurrent bleeding diathesis or major bleeding history requiring discontinuation of antiplatelet drugs. Patients with left main stem stenosis (>50% by visual estimate) or left main stenting Concomitant disease requiring long-term use of clopidogrel (stroke, peripheral vascular disease, significant carotid a. disease, etc)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jung Park, MD, PhD
Organizational Affiliation
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Choeng Ju St.Mary's Hospital
City
Choeng Ju
Country
Korea, Republic of
Facility Name
Kangwon National University Hospital
City
Chuncheon
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
DongGuk University Gyongju Hospital
City
Gyongju
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Kwangju Christian Hospital
City
Kwangju
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyungsang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Veterans Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20231231
Citation
Park SJ, Park DW, Kim YH, Kang SJ, Lee SW, Lee CW, Han KH, Park SW, Yun SC, Lee SG, Rha SW, Seong IW, Jeong MH, Hur SH, Lee NH, Yoon J, Yang JY, Lee BK, Choi YJ, Chung WS, Lim DS, Cheong SS, Kim KS, Chae JK, Nah DY, Jeon DS, Seung KB, Jang JS, Park HS, Lee K. Duration of dual antiplatelet therapy after implantation of drug-eluting stents. N Engl J Med. 2010 Apr 15;362(15):1374-82. doi: 10.1056/NEJMoa1001266. Epub 2010 Mar 15.
Results Reference
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Association of Clopidogrel Therapy and Stent Thrombosis

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