A Prospective, Multicenter, Single-arm Study Designed to Assess the Safety of 3-month Dual Antiplatelet Therapy (DAPT) in Subjects at High Risk for Bleeding Undergoing Percutaneous Coronary Intervention (PCI) With the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,009
- 试验地点
- 110
- 主要终点
- Number of Participants Who Experienced Stent Thrombosis (ST)
研究概览
简要总结
The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a SYNERGY Stent System.
详细描述
The primary objective of the EVOLVE Short DAPT Study is to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Stent System.
The study will be conducted up to 120 sites worldwide in the United States, Europe, Japan, and Brazil with planned enrollment of up to 2,250 subjects. Clinical follow-up will be required at the following time points: 3 months, 6 months, 12 months and 15 months post index procedure.
Subjects must be treated with one of the following P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor) for 3 months following the index procedure. Subjects must be treated with aspirin for the duration of the trial. The minimum daily maintenance dose of aspirin should be 75-100 mg.
Subjects are eligible for discontinuation of P2Y12 inhibitor at 3 months if they meet both of the following criteria: subject was treated with 3 months of study required antiplatelet therapy post index procedure; and subject was free from events (stroke, MI, PCI, coronary artery bypass graft [CABG], and stent thrombosis) between the index procedure and the 3 month visit.
Subjects are not eligible for discontinuation of P2Y12 inhibitor at 3 months if any of the following criteria are met: subject who experiences a stroke, MI, PCI, CABG and/or stent thrombosis, during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit); or subject who is non-compliant with study required antiplatelet therapy during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit); or subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months due to another condition requiring chronic P2Y12 inhibitor use.
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
- •Subject is considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment:
- •≥ 75 years of age and, in the opinion of the investigator, the risk of major bleeding associated with >3 months of DAPT outweighs the benefit,
- •need for chronic or lifelong anticoagulation,
- •history of major bleeding (severe/life threatening or moderate bleeding based on the GUSTO classification) within 12 months of the index procedure,
- •history of stroke (ischemic or hemorrhagic),
- •renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent),
- •platelet count ≤100,000/μL
- •Subject must be at least 18 years of age
- •Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days
- •Subject must be able to take study required antiplatelet therapy (as required per protocol)
- •Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at the 3-month milestone, if eligible per protocol
- •Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed
- •For subjects less than 20 years of age enrolled at a Japanese site, the subject/ the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed
排除标准
- •Subject with an indication for the index procedure of acute ST elevation MI (STEMI)
- •Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
- •Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure
- •Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).
- •Subject has a known allergy to contrast (that cannot be adequately pre-medicated), the SYNERGY stent system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors and aspirin)
- •Subject with implantation of a drug-eluting stent within 9 months prior to index procedure
- •Subject previously treated at any time with intravascular brachytherapy
- •Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
- •Subject is participating in an investigational drug or device clinical trial that has not reached its primary endpoint (Note: registry, observational, data collection studies are not exclusionary)
- •Subject intends to participate in an investigational drug or device clinical trial within 15 months following the index procedure (Note: registry, observational, data collection studies are not exclusionary)
- •Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use
- •Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure
- •Subject is a woman who is pregnant or nursing
- •Subject with a current medical condition with a life expectancy of less than 15 months
- •Target lesion(s) is located in the left main
- •Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
- •Subject has unprotected left main coronary artery disease ( > 50% diameter stenosis)
- •Planned treatment of more than 3 lesion
- •Planned treatment of lesions in more than 2 major epicardial vessels
- •Target lesion(s) treated that involve complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)
- •Target lesion(s) is restenotic from a previous stent implantation
- •Target lesion(s) is located within a saphenous vein graft or an arterial graft
- •Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
- •Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
研究组 & 干预措施
SYNERGY stent + 3 month DAPT
Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)
干预措施: 3 months of dual antiplatelet therapy (DAPT) (Drug)
SYNERGY stent + 3 month DAPT
Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)
干预措施: SYNERGY Stent System (Device)
结局指标
主要结局
Number of Participants Who Experienced Stent Thrombosis (ST)
时间窗: 3 to 15 months
Rate of stent thrombosis: definite + probable, using the Academic Research Consortium (ARC) definition Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed) Probable Clinical definition of probable stent thrombosis is considered to have occurred in the following cases: * Any unexplained death within the first 30 days * Irrespective of the time after the index procedure and MI in the absence of any obvious cause which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis Possible Clinical definition of possible stent thrombosis is considered to have occurred with any unexplained death beyond 30 days.
Number of Participants Who Experienced Death or Myocardial Infarction (MI)
时间窗: 3 to 15 months
Rate of death or myocardial infarction
次要结局
- Number of Participants Who Experienced Major Bleeding(3 to 15 months)