Efficacy and Safety of New Generation Drug Eluting Stents Associated With an Ultra Short Duration of Dual Antiplatelet Therapy. Design of the Short Duration of Dual antiplatElet Therapy With SyNergy II Stent in Patients Older Than 75 Years Undergoing Percutaneous Coronary Revascularization.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ceric Sàrl
- 入组人数
- 1,200
- 试验地点
- 83
- 主要终点
- Composite measure of MACCEs (Major Adverse Cardiac and Cerebrovascular Events)
研究概览
简要总结
The main objective of the SENIOR study is to establish the efficacy and safety of the everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable angina, silent ischemia (1 month DAPT) or acute coronary syndromes (6 months DAPT) related to significant coronary artery disease and requiring percutaneous coronary intervention. The primary end point is to demonstrate that SYNERGY II in patients ≥75 years old is associated with a lower rate of the composite rate of major cardiovascular and cerebrovascular events (all-cause death, myocardial infarction, stroke, ischemia-driven target lesion revascularization) and a similar risk of stent thrombosis than bare metal stent at one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Patient is ≥ 75 years old
- •2- One or more significant coronary artery stenosis is/are present (defined as ≥70% by visual assessment or ≥50% with Fractional Flow Reserve <0.80) or a left main coronary stenosis ≥50% by visual assessment) suitable for PCI with one of the following present:
- •a -Silent ischemia,
- •stress-induced myocardial ischemia ≥ 10% of myocardium in a asymptomatic patient or
- •stress-induced myocardial ischemia < 10% of myocardium AND FFR (Fractional Flow Reserve) ≤0.80 or
- •b - Stable angina, in a patient with objective ischemia despite optimal medical therapy or
- •c - acute coronary syndrome including: unstable angina, non ST- and ST elevation myocardial infarction.
- •3- All patients must also sign informed consent as per local law and comply with all study process during follow up for at least one year.
排除标准
- •1- The subject is not eligible for randomization if ANY of the following is present:
- •2- Indication for myocardial revascularization by coronary artery bypass grafting,
- •3- Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one month (stable angina or silent ischemia) or at least six month (acute coronary syndrome),
- •4- Subjects requiring additional surgery (cardiac or non-cardiac) within one month,
- •5- Non cardiac co-morbidities with life expectancy less than 1 year,
- •6- Prior hemorrhagic stroke,
- •7- Known allergy to aspirin or P2Y12 inhibitors,
- •8- At least one contra indication to ALL the authorized P2Y12 inhibitors at the requested dose (in case of contra indication to only one of two of the P2Y12 inhibitors, the investigators are allowed to use the P2Y12 inhibitors for which no allergy is known).
- •9- Silent ischemia <10% of the myocardium with FFR ≥0.
- •10- Participation in another clinical trial
结局指标
主要结局
Composite measure of MACCEs (Major Adverse Cardiac and Cerebrovascular Events)
时间窗: 12 months
all-cause death, non fatal myocardial infarction, non fatal stroke, ischemia-driven target lesion revascularization.
次要结局
- Cost effectiveness(12 months)
- Primary endpoint(30 days, 180 days, 2 years)
- Complete revascularization(Baseline procedure)
- Stent thombosis(30 days, 1 year, 2 years)
- QoL(12 months, 24 months)
- All revascularizations(30 days, 180 days, 1 year, 2 years)
- Net benefit(30 days, 180 daysn 1 year, 2 years)
- Major bleedings complications(30 days, 180 days, 1 year, 2 years)
- Depression scale(12 months, 24 months)