Randomized Trial of Different Loading Dose of Ticagrelor for Antiplatelet Effect in Patients With Non -ST-segment Elevation ACS Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Platelet Reactivity Index(PRI) Measured by VASP-P
研究概览
简要总结
It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus conventional loading dose(180mg) will result in a higher inhibition of platelet aggregation(IPA) without increasing the bleeding events.
详细描述
After providing written informed consent, all patients will be randomized to receive ticagrelor 360mg or 180mg loading dose(LD),then 90mg bid maintenance dose starting 12 hours after LD.PCI will performed in 2h-72h after they are given the loading dose.All patients should receive acetylsalicylic acid (ASA) 75 to 100 mg daily unless intolerant.IPA at 0, 0.5, 1, 2, 8, 24h after the loading dose of ticagrelor will be measured. CK-MB, troponin I, myoglobin, CRP will be detected at 0h, before PCI, 8h after PCI, 24h after PCI. ECG will be conducted at 0h and within 24h after PCI. Patients returned 28 days for follow-up visits after the loading dose of ticagrelor, documented any adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Provision of informed consent prior to any study specific procedures.
- •Male or non-pregnant female; aged from 18 to 80 years old.
- •Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to undergoing PCI.
排除标准
- •Any contraindication against the use of ticagrelor.
- •On treatment with a P2Y12 receptor antagonist in past 30 days.
- •Known allergies to aspirin or ticagrelor.
- •On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
- •Known blood dyscrasia or bleeding diathesis.
- •ST-segment elevation acute myocardial infarction.
- •Non-ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography.
- •Left ventricular ejection fraction ≤30%; renal failure with creatinine 3 mg/dl; history of liver disease; an increased risk of bradycardia, and concomitant therapy with drugs interfering with CYP3A4 metabolism.
研究组 & 干预措施
high loading dose of ticagrelor
Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
干预措施: ticagrelor (Drug)
conventional loading dose of ticagrelor
Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
干预措施: ticagrelor (Drug)
结局指标
主要结局
Platelet Reactivity Index(PRI) Measured by VASP-P
时间窗: 2 hours after the loading dose of ticagrelor
Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).
次要结局
- Platelet Reactivity Index (PRI) Measured by VASP-P(0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor)
- Bleeding Events(follow-up for 28 days after the loading dose of ticagrelor)