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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
stopping clopidogrel at 1 year after DES
continue aspirin and clopidogrel 1year after DES
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Choeng Ju St.Mary's Hospital
Choeng Ju, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
The composite of cardiac death or MI in the intent-to-treat population
Time frame: 1 year after randomization
All death
Time frame: 1 year after randomization
Myocardial infarction
Time frame: 1 year after randomization
Stroke
Time frame: 1 year after randomization
Stent Thrombosis
Time frame: 1 year after randomization
Bleeding events
Time frame: 1 year after randomization
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Chungnam National University Hospital
Daejeon, South Korea
Asan Medical Center
Gangneung, South Korea
DongGuk University Gyongju Hospital
Gyongju, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Kwangju Christian Hospital
Kwangju, South Korea
Asan Medical Center
Seoul, South Korea
Hangang Sacred Heart Hospital
Seoul, South Korea
...and 3 more locations