Pharmacodynamic Evaluation of Clopidogrel Plus PA32540: The Spaced PA32540 With Clopidogrel Interaction Gauging (SPACING) Study
Pharmacodynamic Evaluation of Clopidogrel Plus PA32540: The Spaced PA32540 With Clopidogrel Interaction Gauging (SPACING) Study
复制标题
DOI：
10.1038/clpt.2011.201
复制
发表时间：
2011-12-01
影响因子：
6.7
通讯作者：
Tantry, U. S.
中科院分区：
文献类型：
--
作者：
Gurbel, P. A.;Bliden, K. P.;Tantry, U. S.
PA 32540联合325 mg肠溶（EC）阿司匹林（阿萨）和40 mg即释奥美拉唑;其对氯吡格雷（C）抗血小板作用的影响未知。在这项随机化、开放标签研究中，受试者（n = 30）接受（i）300 mg C + 325 mg ECASA治疗，随后在第2-7天接受75 mg C + 325 mg ECASA治疗，（ii）300 mg C + PA 32540治疗，随后在第2-7天接受75 mg C + PA 32540治疗，或（iii）第1天早晨给予PA 32540 + 10 h后给予300 mg C，第2-7天早晨给予PA 32540 + 10 h后给予75 mg C。我们分析了PA 32540相对于ECASA的非劣效性，定义为95%置信区间的上限
PA32540 combines 325 mg enteric-coated (EC) aspirin (ASA) with 40 mg immediate-release omeprazole; its influence on the antiplatelet effect of clopidogrel (C) is unknown. In this randomized, open-label study, subjects (n = 30) were treated with (i) 300 mg C + 325 mg ECASA followed by 75 mg C + 325 mg ECASA on days 2-7, (ii) 300 mg C + PA32540 followed by 75 mg C + PA32540 on days 2-7, or (iii) PA32540 in the morning + 300 mg C 10 h later on day 1 and PA32540 in the morning + 75 mg C 10 h later on days 2-7. We analyzed the noninferiority of PA32540 relative to ECASA, as defined by the upper bound of the 95% confidence interval