Perioperative Risk Factors for the Development of Aspirin Low Response in Patients Undergoing Vascular Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing
研究概览
简要总结
Reduced antiplatelet activity (low response (LR)/high on-treatment platelet reactivity (HPR)) of aspirin (ALR) or clopidogrel (CLR) is associated with an increased risk of thromboembolic events. The prevalence figures for low-responders reported in the literature vary widely and there have been few investigations in vascular surgery patients to date. The aim of this prospective monocentric study was to increase the evidence base on vascular surgery patients and to detect any changes in the response following vascular surgery procedures.
详细描述
The activity of aspirin (acetylsalicylic acid, ASA) and clopidogrel is measured by whole blood impedance aggregometry using a multiple electrode aggregometer (Multiplate). The agonists used are arachidonic acid for aspirin and adenosine diphosphate (ADP) for clopidogrel. Vascular patients requiring treatment for peripheral artery disease (PAD) and/or carotid stenosis are included in the study. To identify possible risk factors demographic data, concomitant medication, laboratory parameters, co-morbidities, severity of the condition and the type of procedure performed are documented. In addition, a follow-up aggregometry is performed after completion of the vascular procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vascular patients requiring treatment for peripheral artery disease (PAD) and/or carotid stenosis are included in the study.
排除标准
- •non-adherence to the antiplatelet medication
- •abnormal platelet count in patients,
- •current gastrointestinal disorders,
- •current infections,
- •serious concomitant medical conditions (such as recent gastrointestinal bleeding, cancer, severe cardiac or liver disorders)
- •known bleeding or coagulation disorders,
研究组 & 干预措施
Experimental: aspirin, clopidogrel
Perioperative measurement of ASA and clopidogrel resistance in patients undergoing vascular treatment
干预措施: Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel). (Drug)
结局指标
主要结局
Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing
时间窗: 2 years
In patients treated with aspirin and clopidogrel aggregometry was performed and depending on the results the patients were either responder or low-responder of antiplatelet therapy.
次要结局
未报告次要终点
研究者
Dr. Thomas Hummel
Thomas Hummel MD, head of the arterial department, vice head of the vascular department
St. Josef Hospital Bochum