VerifyNow® PRUTest® Cardiovascular Population Expected Values On-Drug Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- PRUTest
研究概览
简要总结
The purpose of this study is to determine the range of expected PRUTest values in patients in the intended use population receiving dual antiplatelet treatment with aspirin and prasugrel (Effient®), or ticagrelor (Brilinta®).
详细描述
The on-drug reference range study will be performed by measuring venous blood samples in duplicate collected from patients receiving prasugrel (Effient®), or ticagrelor (Brilinta®). Subjects must be on aspirin at the doses prescribed by their treating physician.
When possible, venous blood samples may be collected in conjunction with routine laboratory testing, to minimize the number of needle sticks for the subject. Alternatively, samples may be collected separately to complete the study.
A CBC measurement must be performed for each enrolled subject from a sample collected at the time of blood draw or within ± one week and tested at a certified laboratory. Samples for PRUTest collected in conjunction with a CBC must be drawn after the PRUTest sample.
Up to 130 subjects will be enrolled in the study to facilitate collection of the minimum number of blood samples needed to determine the on-drug reference range of prasugrel (Effient®), or ticagrelor (Brilinta®).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Males and females 18 years and older
- •Able and willing to provide written informed consent.
- •Current treatment with aspirin (any dose).
- •Have a planned or scheduled percutaneous coronary intervention (PCI) with the potential to receive treatment with prasugrel (Effient®), or ticagrelor (Brilinta®) following an oral loading dose or on maintenance treatment for a minimum of seven days who may have symptomatic cerebrovascular disease (transient ischemic attack or following a thrombotic stroke) or cardiovascular disease.
排除标准
- •• Unable to provide written informed consent.
- •Currently receiving an investigational antiplatelet agent.
- •GP IIb/IIIa therapy (ReoPro®, Integrilin®, Aggrastat®) within the past 2 weeks.
- •Received any therapy containing dipyridamole (Persantine®, Aggrenox®) within the past 2 weeks.
- •Women who may be pregnant or are of child bearing potential
结局指标
主要结局
PRUTest
时间窗: Within 24 hours of the loading or last maintance dose
VerifyNow PRUTest results
次要结局
未报告次要终点