Association of Clopidogrel Therapy and Stent Thrombosis
Information source: CardioVascular Research Foundation, Korea
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Aspirin monotherapy (Drug); Aspirin,Clopidogrel (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Seung-Jung Park Official(s) and/or principal investigator(s): Seung-Jung Park, MD, PhD, Principal Investigator, Affiliation: Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
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.
Clinical Details
Official title: Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated With Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The composite of cardiac death or MI in the intent-to-treat population
Secondary outcome: All deathMyocardial infarction Stroke Stent Thrombosis Bleeding 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
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 138-736, Korea, Republic of
Hangang Sacred Heart Hospital, Seoul, Korea, Republic of
Kyungsang University Hospital, Seoul, Korea, Republic of
Seoul Veterans Hospital, Seoul, Korea, Republic of
Ulsan University Hospital, Ulsan, Korea, Republic of
Additional Information
Starting date: March 2007
Last updated: August 9, 2012
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