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
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,023
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac Events (MACE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients will need to have symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, or acute coronary syndromes (including NSTE-ACS and STE-ACS) and presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft that treated with one or multiple Synergy® stents.
- •Moreover, in order to be included patients will need to meet at least 1 of the following HBR criteria:
- •Age ≥75 years
- •Oral anticoagulation planned to continue after PCI
- •Hemoglobin <11 g/l,
- •Transfusion within 4 week before inclusion
- •Platelet count <100'000
- •Hospital admission for bleeding in previous 12 months
- •Stroke in previous 12 months
- •History of intracerebral hemorrhage
- •Severe chronic liver disease
- •Creatinine clearance <40 ml/min
- •Cancer in previous 3 years
- •Planned major surgery in next 12 months
- •Glucocorticoids or NSAID planned for >30 days after PCI
- •Expected non-adherence to >30 days of dual antiplatelet therapy
排除标准
- •Cardiogenic shock
- •Major active bleeding at the time of PCI
- •Expected non-adherence with 1 month DAPT
- •Known intolerance to aspirin, clopidogrel, or ticagrelor
- •Inability to provide informed consent
- •Currently participating in another trial before reaching first endpoint
研究组 & 干预措施
Study arm
1023 real world high-bleeding risk (HBR) patients with coronary artery disease (stable as well as acute coronary syndromes) who qualify for percutaneous coronary interventions will be included in the study.
干预措施: Aspirin (Drug)
Study arm
1023 real world high-bleeding risk (HBR) patients with coronary artery disease (stable as well as acute coronary syndromes) who qualify for percutaneous coronary interventions will be included in the study.
干预措施: P2Y12 inhibitor (Drug)
结局指标
主要结局
Major Adverse Cardiac Events (MACE)
时间窗: 1 year
Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis
次要结局
- Cardiac death(30 days and 1 year)
- Myocardial infarction(30 days and 1 year)
- Target-lesion revascularization(30 days and 1 year)
- Patient oriented composite endpoint(30 days and 1 year)
- All-cause death(30 days and 1 year)
- Stent thrombosis(30 days and 1 year)
- Target-vessel revascularization(30 days and 1 year)
- Major bleeding(30 days and 1 year)
- Target-lesion failure(30 days and 1 year)
- Cerebrovascular event(30 days and 1 year)
研究者
Giulio Stefanini
Assistant Professor of Cardiology
Humanitas Hospital, Italy