Association of Clopidogrel Therapy and Stent Thrombosis
- Conditions
- Coronary Artery Disease
- Interventions
- Drug: Aspirin,Clopidogrel
- Registration Number
- NCT00484926
- Lead Sponsor
- Seung-Jung Park
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aspirin Aspirin monotherapy Aspirin monotherapy (stopping clopidogrel at 1 year after DES) Aspirin,Clopidogrel Aspirin,Clopidogrel Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES)
- Primary Outcome Measures
Name Time Method The composite of cardiac death or MI in the intent-to-treat population 1 year after randomization
- Secondary Outcome Measures
Name Time Method Bleeding events 1 year after randomization Stroke 1 year after randomization Stent Thrombosis 1 year after randomization All death 1 year after randomization Myocardial infarction 1 year after randomization
Trial Locations
- Locations (12)
Seoul Veterans Hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of
Choeng Ju St.Mary's Hospital
🇰🇷Choeng Ju, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
DongGuk University Gyongju Hospital
🇰🇷Gyongju, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Kwangju Christian Hospital
🇰🇷Kwangju, Korea, Republic of
Hangang Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Kyungsang University Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of