NCT01706510已完成4 期
A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease
Rapid City Regional Hospital, Inc1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Compare ticagrelor's versus clopidogrel's inhibition of the P2Y12 receptor as measured by the decrease in P2Y12 Reaction Units (PRU) using VerifyNow TM.
研究概览
简要总结
Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients with stable coronary artery disease.
详细描述
A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Documented stable CAD fulfilling any of the following, and taking 81mg ASA daily treatment:
- •Females must be post menopausal for at least one year or surgically sterile for at least 6 months and negative urine pregnancy test
- •Self-identified as American Indian
- •Genetic Inclusion Criteria: must sign the informed consent for genetic and biological sample banking.
排除标准
- •Any indication for oral anticoagulant or dual antiplatelet treatment
- •Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers within 14 days and during study treatment and during:
- •Increased bleeding risk including:
- •Diabetic patients with HbAlC > 10% at screening
- •Contraindication to clopidogrel, ASA, or ticagrelor - A history of alcohol and/or substance abuse that could interfere with conduct of the trial
- •Patients requiring dialysis
- •Patients scheduled for revascularization (e.g., PCI, CABG) during the study period
- •Any acute or chronic unstable condition in the past 30 days
- •Known active or recurrent hepatic disorder
- •Patients who had ACS or stent placed within 12 months of screening
- •History of Uric Acid nephropathy
研究组 & 干预措施
Ticagrelor
Experimental
Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
干预措施: Ticagrelor (Drug)
Ticagrelor
Experimental
Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
干预措施: Clopidogrel (Drug)
Clopidogrel
Active Comparator
Clopidogrel 600 mg Loading Dose followed by 75 mg Daily for 7 days ± 2 days
干预措施: Ticagrelor (Drug)
Clopidogrel
Active Comparator
Clopidogrel 600 mg Loading Dose followed by 75 mg Daily for 7 days ± 2 days
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Compare ticagrelor's versus clopidogrel's inhibition of the P2Y12 receptor as measured by the decrease in P2Y12 Reaction Units (PRU) using VerifyNow TM.
时间窗: At 2 hour time point after loading dose
次要结局
- Compare the decrease in P2Y l2 Reaction Units (PRU) by VerifyNow™ from ticagrelor's and clopidogrel's morning dose on Day 7(At the 2, 8, and 24 hours after the last dose)
- To evaluate and compare the pharmacodynamic effects, measured by the vasodilator-stimulated phosphoprotein (VASP) assay (platelet reactivity index [PRI]), in all subjects(Day1: pre-dose, 0.5, 2, and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours post final dose)
- Compare the decrease of P2Y12 Reaction Units (PRU) by VerifyNow TM from ticagrelor and clopidogrel.(0.5 and 8 hour time points after loading dose)
- Assess and to compare the percentage of subjects with High on-treatment Platelet Reactivity (HPR) at all time points after randomized study treatment.(Day 1: Pre-dose, 0.5, 2 and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours after final dose)
研究者
研究点 (1)
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