Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event
Not Applicable
- Conditions
- Patients with ACS or elective indications undergoing PCI with drug-eluting stent implantation.
- Registration Number
- JPRN-UMIN000020332
- Lead Sponsor
- Toho University Ohashi Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6422
Inclusion Criteria
Not provided
Exclusion Criteria
Patients are excluded from the study if the following criteria is met: Patients who are in or plan to participate in such clinical study/ research before the end of follow-up in this study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: The incidence of the composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and stent thrombosis at 12 months after index PCI. Safety: The incidence of major bleeding at 12 months after index PCI. (Major bleeding: BARC type 3 or type 5)
- Secondary Outcome Measures
Name Time Method The incidence of the events listed below within 1 month and 30 months after index PCI. The incidence of composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, stent thrombosis The incidence of major bleeding. The incidence of the events listed below within 1 month, 12 months and 30 months after index PCI. Bleeding event (each category according to BARC criteria; major bleeding and minor bleeding according to TIMI criteria). Major adverse clinical, cardiac or cerebral events (all-cause death, cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, nonfatal ischemic stroke, revascularization (TVR, TLR), TIA, stent thrombosis, and peripheral arterial occlusive disease)