PharmacOdynaMic Effects of Cangrelor in PatiEnts wIth Acute or chronIc Coronary Syndrome Undergoing Percutaneous Coronary Intervention (POMPEII Registry)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l
研究概览
简要总结
This prospective registry was designed to carefully investigate the pharmacodynamic (PD) effects of cangrelor in all patients undergoing percutaneous coronary intervention (PCI).
详细描述
There is huge interest in achieving fast and immediate antiplatelet effect at the time of PCI, particularly in acute myocardial infarction and Cangrelor is an intravenous antagonist of the P2Y12 receptor characterized by rapid, potent, predictable, and reversible platelet inhibition. However, there are limited pharmacodynamic data exploring the effects of this drug in the various clinical settings at the approved dosages and with current gold standard methods for testing platelet reactivity. More importantly, there are no data on rates and predictors of high residual platelet reactivity (HRPR) in patients treated with cangrelor. Therefore the present study aims at building up a large prospective registry of pharmacodynamic data obtained by light transmittance aggregometry (LTA), multiplate analysis and verifynow system in patients undergoing PCI and receiving cangrelor.
This study is designed as a single-center prospective registry. Investigators at University Hospital of Naples Federico II will enroll patients, collect blood samples, perform platelet function tests and collect clinical and demographic information.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •All adult patients undergoing PCI and receiving cangrelor administration will be eligible for inclusion in the study.
排除标准
- •only those not providing consent to blood/data collection will be excluded.
结局指标
主要结局
Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l
时间窗: 30 minutes
Platelet inhibition assessed with LTA-ADP 20 µmol/l at 30 minutes and after infusion stop
次要结局
- Inhibition of platelet activity (IPA, %) with LTA-ADP 5 µmol/l(30 minutes)
- Platelet aggregation, inhibition and HRPR by LTA, Multiplate and VerifyNow(After stop of cangrelor infusion)
- Rates of HRPR defined as Multiplate AUC >46 U(30 minutes)
- Maximum platelet aggregation (MPA) with LTA-ADP 20 µmol/l(30 minutes)
- Rates of HRPR defined as VerifyNow PRU >208(30 minutes)
- Maximum platelet aggregation (MPA) with LTA-ADP 5 µmol/l(30 minutes)
- Rates of High Residual Platelet Reactivity (HRPR) with LTA-ADP 20 µmol/l defined as MPA>59%(30 minutes)
- Rates of High Residual Platelet Reactivity with LTA-ADP 5 µmol/l defined as MPA>46%(30 minutes)
- Area under the curve (AUC) at Multiplate with ADP test(30 minutes)
- P2Y12 Reaction Unit (PRU) at VerifyNow(30 minutes)
- Clinical outcomes at 30 days(30 day)
研究者
Giuseppe Gargiulo
Principal investigator
Federico II University