Comparison of Loading Strategies With Antiplatelet Drugs in Patients Undergoing Elective Coronary Intervention (SASSICAIA)
2020年7月15日 更新者：Prof. Dr. Julinda Mehilli、LMU Klinikum
Intensified Loading With Prasugrel Versus Standard Loading With Clopidogrel in Invasive-treated Patients With Biomarker-Negative Angina Pectoris
Use of high loading doses of clopidogrel (antiplatelet drug) just before coronary interventions is associated with improved outcomes after coronary stenting.
However the onset of platelet inhibition after clopidogrel loading takes 2 to 4 hours and its action if very variable.
A way to overcome this limitation is loading with a more potent antiplatelet drug such as prasugrel.
Therefore in the current study the investigators want to compare loading with 60 mg prasugrel (potent antiplatelet drug) and loading with clopidogrel (standard drug) in patients undergoing elective coronary intervention.
研究概览
详细说明
Patients with stable or clinically unstable (biomarker-negative) angina pectoris who are in need of coronary intervention will be randomly assigned in one of the treatment strategies - 60 mg of prasugrel or 600 mg clopidogrel just prior to percutaneous coronary intervention (PCI).
After PCI all patients will receive clopidogrel 75 mg/d as per standard.
The patients will be monitored throughout a 30-day time frame and ischemic and bleeding events will be recorded.
The study is powered to show the superiority of single-dose 60 mg prasugrel over single-dose 600 mg clopidogrel regarding the ischemic complications at 30-day follow-up.
研究类型
介入性
注册 (实际的)
795
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Balatonfüred、匈牙利
- Heart Center Balatonfüred and Heart and Vascular Center
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Munich、德国、80636
- Deutsches Herzzentrum Muenchen
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Munich、德国
- Klinikum Bogenhausen
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Bad Krozingen
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Freiburg、Bad Krozingen、德国、79189
- Universitäts-Herzzentrum Freiburg, Bad Krozingen
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Bavaria
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Munich、Bavaria、德国、81377
- Munich University Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with biomarker negative stable or unstable angina pectoris
- Written informed consent
- In women with childbearing potential a pregnancy test is obligatory
Exclusion Criteria:
- Age < 18 years and >80 years
- ST-elevation MI
- Elevated cardiac biomarkers
- Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage and with known severe liver disease (Child Pugh Class C)
- Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage and a history of prior transient ischemic attack (TIA) or stroke and with known severe liver disease (Child Pugh Class C)
- Chronic therapy on potent P2Y12 receptor inhibitors (ticagrelor, prasugrel)
- Pre-treatment with a loading dose of either clopidogrel, prasugrel or ticagrelor
- Simultaneous participation in another clinical trial that involves the administration of an investigational medicinal drug within 30 days prior to the start of this clinical trial
- Major surgeries in the last 6 weeks and planned surgeries within the next 6 weeks (per decision of the treating physician)
- Active bleeding
- Known or persistent abuse of medication, drugs or alcohol
- Current or planned pregnancy or nursing women, women 90 days after childbirth. Females of childbearing potential, who do not use and are not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Prasugrel
single-dose loading with 60 mg of prasugrel pre PCI
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see arm description
其他名称：
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有源比较器：Clopidogrel
loading with 600 mg of clopidogrel pre PCI
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见手臂描述
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Combined ischemic events
大体时间：30 days
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Combined outcome of all-cause death, any myocardial infarction (MI), stent thrombosis, urgent revascularization and stroke
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30 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Bleeding
大体时间：30 days
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Academic Research Consortium ≥2 bleeding and TIMI classification
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30 days
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Peri-PCI MI Type 4a
大体时间：30 days
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according to Third Universal Definition of MI
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30 days
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All-cause death
大体时间：30 days
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mortality
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30 days
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Any myocardial infarction
大体时间：30 days
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according to SASSICAIA protocol definition
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30 days
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Stent thrombosis
大体时间：30 days
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according to Academic Research Consortium criteria
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30 days
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Urgent vessel revascularization
大体时间：30 days
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revascularization related to symptoms
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30 days
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cerebro-vascular events
大体时间：30 days
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stroke and TIA
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30 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Julinda Mehilli, MD、University Hospital Munich
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年9月1日
初级完成 (实际的)
2018年8月1日
研究完成 (实际的)
2018年11月1日
研究注册日期
首次提交
2015年9月10日
首先提交符合 QC 标准的
2015年9月11日
首次发布 (估计)
2015年9月14日
研究记录更新
最后更新发布 (实际的)
2020年7月17日
上次提交的符合 QC 标准的更新
2020年7月15日
最后验证
2020年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.