Impact of Evolocumab on the Antiplatelet Effects of Ticagrelor and Aspirin in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Platelet Reactivity Defined by VerifyNow PU in Patients diagnosed ACS
研究概览
简要总结
The aim of the present study is to investigate the effects of evolocumab in addition to statin therapy on platelet reactivity in patients with acute coronary syndrome (ACS) while on Ticagrelor and Aspirin treatment.
详细描述
Ticagrelor is a commercially available antiplatelet adenosine diphosphate (ADP) antagonists. They exert their antiplatelet effects by binding to P2Y12 receptors on the platelet surface. Ticagrelor is used in combination with aspirin to prevent and treat thrombosis in patients with acute coronary syndrome, particularly after stent implantation.
Aspirin has an established role in the treatment of ACS and secondary prevention of ischaemic heart disease. Aspirin inhibits cyclo-oxygenase (COX) enzymes by irreversible acetylation to block platelet aggregation.
Evolocumab is a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). The use of evolocumab significantly reduced the incidence of cardiovascular events compared to statins alone. Whether the reduction in cardiovascular events is due to LDL reduction or other mechanisms is currently unclear.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were diagnosed as acute coronary disease
- •On therapy with Ticagrelor(90mg bid) and Aspirin(100mg qd), for at least 5 days.
- •Fasting LDL-cholesterol ≥70 mg/dL or a non-high-density lipoprotein cholesterol (HDL-C) of ≥100 mg/dL after ≥4 weeks of optimized stable lipid-lowering therapy with maximally tolerated dose of statin.
- •Have not used Evolocumab in 30 days.
排除标准
- •On treatment with any oral anticoagulant.
- •On treatment with any antiplatelet agent other than Aspirin and Ticagrelor in the past 5 days.
- •Creatinine clearance <30 mL/minute.
- •Known severe hepatic impairment.
- •History of a serious hypersensitivity reaction to evolocumab
- •Hemodynamic instability
- •Pregnant and breastfeeding women.
研究组 & 干预措施
24h-Evo
Patients regularly take Ticagrelor and Aspirin for five days, then inject Evolocumab 140mg. Platelet activity was test 24h after inject.
干预措施: Evolocumab (Drug)
1w-Evo
Patients regularly take Ticagrelor and Aspirin for five days, then inject Evolocumab 140mg. Platelet activity was test 1 week after inject.
干预措施: Evolocumab (Drug)
结局指标
主要结局
Platelet Reactivity Defined by VerifyNow PU in Patients diagnosed ACS
时间窗: 1 week
The primary end point of our study is the comparison of P2Y12 reaction units (PU) measured by VerifyNow in patients before use evolocumab and 24hours after injected and 1week after injected. PU is well-established measures of platelet reactivity and aggregation in response to antiplatelet medications. The higher is the PU the lower is the effect of the antiplatelet medication. Validity is defined as PU\<208.
Platelet Reactivity Defined by VerifyNow AU in Patients diagnosed ACS
时间窗: 1 week
The second end point of our study is the comparison of COX-1 reaction units(AU) measured by VerifyNow in patients before use evolocumab and 24hours after injected and 1week after injected. AU is well-established measures of platelet reactivity and aggregation in response to antiplatelet medications. The higher is the AU the lower is the effect of the antiplatelet medication. Validity is defined as AU\<550.
次要结局
未报告次要终点