NCT02319941已完成2 期
Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes; Pharmacodynamics and Pharmacokinetics Study
Seung-Jung Park1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2015年5月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- P2Y12 reaction units(PRU)
研究概览
简要总结
The purpose of this study is to compare Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients with Acute Coronary Syndromes
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ST elevation or non ST elevation acute coronary syndrome patients of chest pain within 24 hours
排除标准
- •Known hypersensitivity to clopidogrel and ticagrelor and aspirin
- •Treatment with anticoagulants
- •Exposure to a thrombolytic agent within 24 hours prior to randomization
- •Use of glycoprotein IIb - IIIa inhibitors at randomization
- •History of major hemorrhage (intracranial, gastrointestinal, etc.)
- •clotting disorder and/or bleeding disorder
- •Any history of Severe renal or hepatic dysfunction
- •Hematologic disorder including a Hemoglobin less than 10 g/L or a platelet count less than 80,000 cells/mm3
- •Cardiac shock, severe left ventricular dysfunction LVEF less than 30%
- •Sick sinus syndrome or second degree of av block without permanent pacemaker
- •No concurrent cytochrome p450 3a inhibitors and enhancers within 2 weeks
- •Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg,drug and alcohol abuse, mental illness) or that could prevent, limit, or confound the protocol-specified assessments.
- •Life expectancy of less than 6 months
- •Pregnancy or lactating
- •Participation in any drug study in the previous 3 months
- •Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk
研究组 & 干预措施
standard dose ticagrelor
Active Comparator
90mg bid
干预措施: ticagrelor (Drug)
Low dose ticagrelor
Experimental
60mg bid
干预措施: ticagrelor (Drug)
standard dose clopidogrel
Active Comparator
75mg qd
干预措施: clopidogrel (Drug)
结局指标
主要结局
P2Y12 reaction units(PRU)
时间窗: 8 hours and 30days after first randomized dose
P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay
次要结局
- Aggregation units(AU), Area Under the Curve(AUC)(0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment)
- Percentage of low-responsive patients(0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment)
- Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX(0, 0.5, 1, 2, 4, 8, 10,24 hours after first randomized study treatment)
- MACE(Major adverse cardiac event)(30 days after first randomized study treatment)
- Adverse event(30 days after first randomized study treatment)
- Percentage inhibition of platelet aggregation(0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment)
- Drug tolerance(30 days after first randomized study treatment)
研究者
Seung-Jung Park
MD, PhD
Asan Medical Center
研究点 (1)
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