Association of Clopidogrel Therapy and Stent Thrombosis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Drug: Aspirin monotherapy Drug: Aspirin,Clopidogrel	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated With Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Aspirin Clopidogrel bisulfate

U.S. FDA Resources

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:

The composite of cardiac death or MI in the intent-to-treat population [ Time Frame: 1 year after randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

All death [ Time Frame: 1 year after randomization ] [ Designated as safety issue: Yes ]
Myocardial infarction [ Time Frame: 1 year after randomization ] [ Designated as safety issue: Yes ]
Stroke [ Time Frame: 1 year after randomization ] [ Designated as safety issue: Yes ]
Stent Thrombosis [ Time Frame: 1 year after randomization ] [ Designated as safety issue: Yes ]
Bleeding events [ Time Frame: 1 year after randomization ] [ Designated as safety issue: Yes ]

Enrollment:	2000
Study Start Date:	March 2007
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Aspirin Aspirin monotherapy (stopping clopidogrel at 1 year after DES)	Drug: Aspirin monotherapy stopping clopidogrel at 1 year after DES Other Name: Aspirin monotherapy
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 Name: Aspirin,Clopidogrel Dual antiplatelet therapy

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484926

Locations

Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Choeng Ju St.Mary's Hospital
Choeng Ju, Korea, Republic of
Kangwon National University Hospital
Chuncheon, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Asan Medical Center
GangNeung, Korea, Republic of
DongGuk University Gyongju Hospital
Gyongju, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Kwangju Christian Hospital
Kwangju, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Kyungsang University Hospital
Seoul, Korea, Republic of
Seoul Veterans Hospital
Seoul, Korea, Republic of
Hangang Sacred Heart Hospital
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of

Sponsors and Collaborators

Seung-Jung Park

CardioVascular Research Foundation, Korea

Investigators

Principal Investigator:

Seung-Jung Park, MD, PhD

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

More Information

No publications provided by CardioVascular Research Foundation, Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Mar 15.

Responsible Party:	Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:	NCT00484926 History of Changes
Other Study ID Numbers:	20070186
Study First Received:	June 11, 2007
Last Updated:	August 9, 2012
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:

coronary disease
stents
antiplatelet drugs
drug-eluting stents

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on June 17, 2013

Association of Clopidogrel Therapy and Stent Thrombosis (REAL-LATE)