NCT01701453Unknown不适用
Smart Angioplasty Research Team: Safety of 6-month Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes (SMART-DATE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 2,712
- 试验地点
- 1
- 主要终点
- A composite of all-cause mortality, spontaneous myocardial infarction (MI), and cerebrovascular event
研究概览
简要总结
- Objective : To test the safety of 6 month-duration of dual antiplatelet therapy (DAPT) compared to conventional 12-month-or-longer duration after second-generation drug-eluting stent (DES) implantation in patients with acute coronary syndrome (ACS).
- Hypothesis : A 6-month duration of DAPT is non-inferior to a conventional 12-month-or longer duration of DAPT at preventing the occurrence of major adverse cardiac and cerebrovascular events (MACCE) at 18-month after second-generation DES implantation in patients with ACS.
详细描述
- Primary endpoint
- MACCE, defined as a composite of all-cause mortality, myocardial infarction, and cerebrovascular events at 18 months after the index procedure.
- Secondary endpoint
- Individual components of the primary endpoint at 18-month after the index procedure
- Definite/probable stent thrombosis, defined by the Academic Research Consortium (ARC) at 18-month after the index procedure.
- Bleeding complication, defined by Bleeding Academic Research Consortium (BARC) type 2 to 5 at 18-month after the index procedure.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be ≥ 20 years.
- •Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving percutaneous coronary intervention and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- •Subject must have a culprit lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation.
- •Subject must have clinical diagnosis of ACS that includes unstable angina and MI. The specific definitions of ACS, as follows; 1) ST-segment elevation MI (STEMI) : elevation of ST-segment more than 0.1 mV in 2 or more contiguous electrocardiographic (ECG) leads or new left bundle-branch block with elevated biomarkers of myocardial necrosis 2) Non-ST-segment elevation MI (NSTEMI) : Elevated biomarkers of myocardial necrosis (troponin or CK-MB > upper reference limit) with one of the following; (a) Transient ST-segment elevation or depression, or T-wave changes consistent with myocardial ischemia, (b) Identification of a culprit lesion at coronary angiography 3) Unstable angina : An accelerating pattern or recurrent episodes of chest pain at rest or with minimal effort and new ST-segment depression of at least 0.05 mV, or T wave inversion of at least 0.3 mV in at least 2 leads. The ECG criteria for unstable angina were based on the TACTICS-TIMI 18 trial.
- •Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.
- •Target lesion(s) must be amenable for percutaneous coronary intervention
排除标准
- •The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus, Everolimus, Zotarolimus, and Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.)
- •Patients with active pathologic bleeding
- •Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- •Systemic (intravenous) Biolimus, everolimus, zotarolimus use within 12 months.
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- •History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
- •Noncardiac comorbid conditions are present with life expectancy <1 year or that may result in protocol noncompliance (per site investigator's medical judgment).
- •An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
研究组 & 干预措施
6 months group
Experimental
6 months duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment
干预措施: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) (Drug)
12 months or longer group
Experimental
12 months or longer duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment
干预措施: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) (Drug)
结局指标
主要结局
A composite of all-cause mortality, spontaneous myocardial infarction (MI), and cerebrovascular event
时间窗: at 18-month after the index procedure
defined as MACCE
次要结局
- Stent thrombosis(at 18-month after the index procedure)
- Spontaneous MI(at 18-month after the index procedure)
- Cerebrovascular event(at 18-month after the index procedure)
- All-cause mortality(at 18-month after the index procedure)
- Bleeding(at 18-month after the index procedure)
研究者
Hyeon-Cheol Gwon
Professor
Samsung Medical Center
研究点 (1)
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