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临床试验/NCT01329224
NCT01329224已完成不适用

Acetylsalicylic Acid in Outpatient Practice - Results From The Antiaggregation Monitoring (TAM) Registry

Stephane Cook1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Whole blood impedance platelet aggregometry to assess acetylsalicylic acid resistance rates

研究概览

简要总结

The purpose of this study is to investigate the incidence of acetylsalicylic acid resistance (ASA-R) among patients under chronic acetylsalicylic acid(ASA) treatment seen at our outpatient clinic.

详细描述

Acetylsalicylic acid (ASA) resistance (R) is best defined as an ineffective inhibition of the platelet cyclooxygenase (COX)-1 pathway, and has been reported in 1 to 61 % of patients treated with ASA. Impaired response to ASA has been associated with an increased risk of ischemic events in patients with known coronary artery disease. We sought to investigate the incidence of ASA-R in clinical practice.

All consecutive patients under chronic ASA treatment (100mg/d) seen at our outpatient clinic were systematically included in the registry. All patients were on acetylsalicylic acid for CAD for at least 1 month. Patients were informed of ASA testing at start of consultation in the outpatient clinic. Eligible patients provided written informed consent. Peripheral venous blood samples were analyzed using the whole blood impedance platelet aggregometry Multiplate analyzer. The Multiplate analyzer device allows to measure platelet aggregation by the attachment of platelets to two silver coated copper electrodes leading to a rise of electrical resistance in the sample. The measurements are expressed as arbitrary aggregation units (AU) and the manufacturers defined cutoffs were used: normal values were 76-136 AU, partial antiaggregation was defined as ASA values between 31 and 75 AU and complete antiaggregation was defined as ASA values < 31 AU.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients under chronic ASA treatment for more then one month

排除标准

  • concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs)
  • thrombocytopenia
  • thrombocytosis
  • age <18 years

结局指标

主要结局

Whole blood impedance platelet aggregometry to assess acetylsalicylic acid resistance rates

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Stephane Cook
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Stephane Cook

Prof.

University Hospital Freiburg

研究点 (1)

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