Association of Clopidogrel Therapy and Stent Thrombosis

NCT00484926 | Completed Phase 4 DMC

• 1 other identifier: 20070186
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 13

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.

Conditions

Coronary Artery Disease

Keywords

coronary disease; stents; antiplatelet drugs; drug-eluting stents

Outcome Measures

Primary Outcomes (1)

• The composite of cardiac death or MI in the intent-to-treat population

  1 year after randomization

Secondary Outcomes (5)

• All death

  1 year after randomization

• Myocardial infarction

  1 year after randomization

• Stroke

  1 year after randomization

• Stent Thrombosis

  1 year after randomization

• Bleeding events

  1 year after randomization

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

Aspirin monotherapy (stopping clopidogrel at 1 year after DES)

Drug: Aspirin monotherapy

Aspirin,Clopidogrel

EXPERIMENTAL

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

Drug: Aspirin,Clopidogrel

Interventions

Aspirin monotherapy DRUG

stopping clopidogrel at 1 year after DES

Aspirin

Aspirin,Clopidogrel DRUG

continue aspirin and clopidogrel 1year after DES

Also known as: Aspirin,Clopidogrel Dual antiplatelet therapy

Aspirin,Clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (13)

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Choeng Ju St.Mary's Hospital

Choeng Ju, South Korea

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Asan Medical Center

Gangneung, South Korea

Location

DongGuk University Gyongju Hospital

Gyongju, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Kwangju Christian Hospital

Kwangju, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Hangang Sacred Heart Hospital

Seoul, South Korea

Location

Kyungsang University Hospital

Seoul, South Korea

Location

Seoul Veterans Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Related Publications (1)

• 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.

  PMID: 20231231 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Seung-Jung Park, MD, PhD

  Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 12, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 10, 2012

Record last verified: 2012-08

Locations

KR (13)