Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 主要终点
- Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer
研究概览
简要总结
The primary objective of this exploratory cohort study is to describe levels of platelet reactivity in patients on a thienopyridine awaiting coronary artery bypass grafting (CABG).
详细描述
The recent emergence of platelet reactivity testing as a potential option for evaluating the degree of platelet inhibition promises to add another level of understanding to our concept of CABG-related bleeding. There is an emerging literature that links high levels of platelet reactivity with adverse clinical events, primarily in patients on clopidogrel.
For example, studies of the VerifyNow P2Y12 platelet function assay have shown that Platelet Reactivity Units (PRU) > 235-240 in patients on clopidogrel therapy appears to predict cardiovascular events.15,16 There is a paucity of literature, however, on the use of platelet reactivity testing to predict bleeding events and complications. In other words, if excessively high levels of platelet reactivity predict ischemic events, do excessively low levels of platelet reactivity predict bleeding events? This is an especially relevant question, given the emergence of prasugrel as a therapeutic option.
The investigators therefore propose an exploratory cohort study of patients receiving a thienopyridine (clopidogrel or prasugrel) and undergoing CABG, in order to describe levels of platelet reactivity in such patients by using a variety of platelet function tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients ≥ 18 years old from both genders.
- •Taking maintenance thienopyridine therapy within 5 days of surgery OR received a loading dose of thienopyridine therapy within 48 hours of surgery for CABG.
- •Referred for CABG (which is scheduled to be performed during the current admission).
排除标准
- •Known allergies to aspirin, clopidogrel, or prasugrel.
- •Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of initial platelet reactivity testing.
- •Patient known to be pregnant or lactating.
- •Patient with known history of bleeding diathesis or currently active bleeding.
- •Platelet count <100,000/mm the day of initial blood draw.
- •Hematocrit <25% the day of initial blood draw.
- •On warfarin therapy at the time of initial blood draw.
- •Known blood transfusion within the preceding 10 days of the blood draw.
- •Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
- •Plan for patient to be discharged before undergoing CABG.
- •Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.
研究组 & 干预措施
CABG
干预措施: Platelet reactivity assessment (Other)
结局指标
主要结局
Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer
时间窗: Duration of hospital stay; average hospital stay of 1 week
Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer, which measures levels of light transmittance after stimulation with ADP to estimate levels of platelet aggregation
Perioperative rates of bleeding complications
时间窗: Duration of hospital stay; average hospital stay of 1 week
Perioperative rates of bleeding complications: 1. need for reoperation because of bleeding 2. need for perioperative red blood cell transfusion (units of packed red blood cells) 3. rates of TIMI, GUSTO, and nuisance bleeding 4. quantity of postoperative drainage (mL)
次要结局
- Serial levels of platelet reactivity, as assessed with the VerifyNow P2Y12 assay(Duration of hospital stay; average hospital stay of 1 week)
- Serial levels of platelet reactivity, as assessed with the Vasodilator Stimulated Phosphoprotein (VASP) assay(Duration of hospital stay; average hospital stay of 1 week)