Coronary Heart Disease, Acute Coronary Syndrome, Acute Myocardial Infarction, Unstable Angina
Conditions
Interventions
After PCI for the ACS patients with Xience, dual antiplatelet therapy (DAPT) will be performed for one month. Following that, clopidogrel monotherapy will be continued up to 5 years after index PCI (1
Sponsors
Kyoto University, Graduate School of Medicine, Department of Cardiovascular Medicine
Research Institute for Production Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have undergone PCI with the everolimus-eluting cobalt-chromium stent (EES, XienceTM) 2. Patients who have not experienced major complications (death, MI, stroke, or major bleeding) during hospital stay for treatment 3. Patients who are capable of oral dual antiplatelet therapy consisting of aspirin and a P2Y12 receptor antagonist
Exclusion criteria
Exclusion criteria: 1. Patients requiring oral anticoagulants 2. Patients with medical history of intracranial hemorrhage 3. Patients who have experienced serious complications (MI, stroke, and major bleeding) during hospital stay post-PCI 4. Patients with DES other than Xience implanted in PCI performed at the time of enrollment 5. Patients confirmed to have no tolerability to clopidogrel before enrollment 6. Patients requiring continuous administration of antiplatelet drugs (PDE3 inhibitors, prostaglandin preparations, etc.) other than aspirin and P2Y12 receptor inhibitors (prasugrel, clopidogrel, and ticlopidine) at the time of enrollment 7. Patients with coronary bioabsorbable vascular scaffold (BVS) implanted prior to or at the time of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite of cardiovascular death, myocardial infarction (MI), stroke (ischemic and hemorrhagic), stent thrombosis (Definite stent thrombosis yet to develop into MI), and severe bleeding (TIMI Major/Minor) at 12 months after index PCI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular death, MI, Stroke, ARC definite ST, Major bleeding (TIMI Major/ Minor) at 12 months after index PCI. Cardiovascular death, MI, Stroke, ARC definite ST, Major bleeding (TIMI Major/ Minor), Upper gastrointestinal endoscopy / upper gastrointestinal endoscopic treatment at 60 months after index PCI. | — |
Countries
Japan
Contacts
Public ContactHirotoshi Watanabe
Kyoto University, Graduate School of Medicine Department of Cardiovascular Medicine
Outcome results
None listed