Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Detection of Platelet Dysfunction Due to P2Y12 Antiplatelet Drugs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 主要终点
- Change in Platelet Activity Index (PAI)
研究概览
简要总结
Study to evaluate the performance of the AggreGuide A-100 ADP assay for detection of platelet dysfunction caused by P2Y12 inhibitor antiplatelet therapy.
详细描述
Study subjects will have A-100 ADP measurements performed at baseline and after initiation of P2Y12 inhibitor antiplatelet therapy, following loading and maintenance doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Platelet function test results are not provided to the participant, care provider, or investigator
入排标准
- 年龄范围
- 22 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has a history of cardiovascular disease OR
- •Subject has 2 or more cardiac risk factors:
- •Hypertension
- •Hyperlipidemia
- •Family History of Heart Disease
- •Post-menopausal female
- •Obesity (BMI > 30)
- •Sedentary lifestyle
排除标准
- •Taken nonsteroidal anti-inflammatory drugs (NSAIDs) drugs, anti-platelet drugs or anticoagulant drugs within the past seven (7) days, over age 75, under 60 kg body weight, in the last trimester of pregnancy or breastfeeding, with a diagnosed history of: stroke or transient ischemic attacks, or other thromboembolic disease, anemia, thrombocytopenia, uncontrolled hypertension,platelet disorders,hemophilia or other bleeding disorder, gastrointestinal disease, severe renal disease, expect to engage in contact sports, scheduled for elective surgery, have a medical history as determined by the Investigator that would pose safety concerns, or possess contraindications for any of the study medications.
研究组 & 干预措施
Clopidogrel
Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.
Loading dose day 1. Maintenance dose over subsequent 7 days.
干预措施: P2Y12 inhibitor (Drug)
Clopidogrel
Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.
Loading dose day 1. Maintenance dose over subsequent 7 days.
干预措施: Platelet function test (Device)
Prasugrel
Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.
Loading dose day 1. Maintenance dose over subsequent 7 days.
干预措施: P2Y12 inhibitor (Drug)
Prasugrel
Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.
Loading dose day 1. Maintenance dose over subsequent 7 days.
干预措施: Platelet function test (Device)
Ticagrelor
Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.
Loading dose day 1. Maintenance dose over subsequent 7 days.
干预措施: P2Y12 inhibitor (Drug)
Ticagrelor
Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.
Loading dose day 1. Maintenance dose over subsequent 7 days.
干预措施: Platelet function test (Device)
结局指标
主要结局
Change in Platelet Activity Index (PAI)
时间窗: Baseline, day 1, day 7
Platelet reactivity measurement using A-100 ADP assay
次要结局
未报告次要终点