Aspirin- and Clopidogrel-Resistance: Non-compliance and Other Contributing Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Platelet aggregation, initial and after one week under compliance monitoring.
研究概览
简要总结
Resistance to antiplatelet drugs (aspirin, clopidogrel) is a recognized phenomenon with a prevalence from 17% to 35%. Resistance as detected by in vitro tests such as Multiple Electrode Aggregometry (MEA) has been shown to predict clinical therapy failure. Resistance can be caused by clinical, cellular and pharmacogenetic factors. Non compliance is suspected to be an important contributing factor. In this study, compliance will be assured with an electronical compliance monitoring system. Factors to non response will be identified to find plausible explanations when in vitro platelet aggregation inhibition is insufficient despite assured compliance. This study will help to disclose the relationship between compliance, biomarker and clinical outcome as well as to quantify the impact of non compliance to the resistance phenomenon as measured by MEA.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients prescribed aspirin and/or clopidogrel for both including both cardiovascular and cerebrovascular indications seeing their general practitioner in or nearby Olten/SO for any medical purpose
- •Patients with oral and written German language ability
排除标准
- •Patients living in care homes
- •Patients not preparing their drugs on their own (e.g. outpatient medical assistance through "spitex").
- •Patients with acute cardiac symptoms
结局指标
主要结局
Platelet aggregation, initial and after one week under compliance monitoring.
时间窗: 1 week
次要结局
- Data on compliance (measured by electronic compliance monitoring, Morisky MMAS-8 and BMQ Score)(1 week)
- Frequency of contributing factors to non-response in responders compared to non-responders (pharmacogenetics, clinical factors and drug-drug interactions)(4 weeks)