Coronary Artery Disease Clinical Trial
Official title:
Performance of Bioresorbable Polymer-Coated Everolimus-Eluting Synergy® Stent in Patients at High Bleeding Risk Undergoing Percutaneous Coronary Revascularization Followed by 1-Month Dual Antiplatelet Therapy
Objective: To evaluate the safety of bioresorbable polymer-coated everolimus-eluting Synergy®
stent followed by 1-month dual antiplatelet therapy in patients at high-bleeding risk.
Study population: Real world high-bleeding risk (HBR) patients with coronary artery disease
(stable as well as acute coronary syndromes) who qualify for percutaneous coronary
interventions.
Study size: A total of 1023 patients will be enrolled. Study design: Prospective, single-arm,
multicentre trial, powered for non-inferiority with respect to objective performance criteria
(OPC).
Antiplatelet therapy: Dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor
for a duration of 1 month, after which single antiplatelet therapy with aspirin will be
recommended indefinitely. In case of need for oral anticoagulation, patients will receive an
oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days.
Primary endpoint: Composite of cardiac death, myocardial infarction, or definite/probable
stent thrombosis at 1-year follow-up.
n/a
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