Elshafei Mohamed Nabil, Imam Yahia, Mohamed Mouhand F H, AlSaud Arwa Ebrahim, Ahmed Mohamed Sayed, Obeidat Khaldun, Saeid Razan, Ali Mohamed, Abdallah Ibtihal M, Parray Aeijaz Sultan, Danjuma Mohammed Ibn-Masoud
Clinical Pharmacy Department.
Neurology Department, Hamad General Hospital, Hamad Medical Corporation.
Medicine (Baltimore). 2020 May;99(20):e20307. doi: 10.1097/MD.0000000000020307.
Uncertainty remains regarding the impact of enteric-coated (EC) aspirin as it relates to the reduction of cardiovascular risk. We hypothesize that EC formulation based on a previous report may blunt aspirin response as evidenced by reduced Thromboxane A2 (TXA 2) levels in diabetic patients. Thus, it was imperative to ascertain and validate the effect of the EC formulation of Aspirin on the Thromboxane B2 (TXB2) level.
METHODS/DESIGN: An open-label consecutive randomized interventional controlled trial. Patients with newly diagnosed ischemic stroke who are just about to start Aspirin were assessed for eligibility and inclusion in our trial. Consecutive patients (admitted to the stroke unit of Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar) will be randomized to receive either EC aspirin or plain Aspirin. They will be required to continue taking them throughout the study (3 days). Demographics and laboratory records of the study participants will be abstracted from online records. Further study variables will be obtained manually in designated case record forms (CRF). The primary outcomes are the incidence of aspirin non-responders (level of residual serum TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses). Whereas secondary outcomes are the incidence of GIT bleeding of various preparations of Aspirin. The study was approved by MRC and IRB of Hamad Medical Corporation (MRC number: 01-18-156).
This trial will determine potential differences in the efficacy of EC Aspirin and plain Aspirin on the Thromboxane B2 level. Additionally, it will ascertain the tolerability and safety of both formulations of Aspirin in patients with newly diagnosed ischemic stroke. These results will either support the current notion of no difference between the two formulations. However, if a difference is found, this will invite for future trials exploring clinical outcomes occurrence between various formulations.
Clinicaltrials.gov NCT04330872 registered on April 2, 2020.
关于肠溶（EC）阿司匹林对降低心血管风险的影响仍存在不确定性。我们假设，根据先前的一份报告，肠溶制剂可能会减弱阿司匹林的反应，这在糖尿病患者血栓素A2（TXA2）水平降低中得到了证实。因此，必须确定并验证阿司匹林肠溶制剂对血栓素B2（TXB2）水平的影响。
方法/设计：一项开放标签的连续随机介入对照试验。对即将开始服用阿司匹林的新诊断缺血性中风患者进行资格评估并纳入我们的试验。连续患者（入住卡塔尔多哈哈马德医疗公司哈马德总医院中风单元）将被随机分配接受肠溶阿司匹林或普通阿司匹林。要求他们在整个研究期间（3天）持续服用。研究参与者的人口统计学和实验室记录将从在线记录中提取。进一步的研究变量将通过指定的病例记录表（CRF）手动获取。主要结局是阿司匹林无反应者的发生率（在每日服用三次阿司匹林后72小时内，残余血清TXB2水平与血栓形成风险升高相关（抑制率<99.0%或TXB2>3.1 ng/mL））。次要结局是各种阿司匹林制剂的胃肠道出血发生率。该研究已获得哈马德医疗公司MRC和IRB的批准（MRC编号：01-18-156）。
本试验将确定肠溶阿司匹林和普通阿司匹林在血栓素B2水平上的疗效潜在差异。此外，它将确定两种阿司匹林制剂在新诊断缺血性中风患者中的耐受性和安全性。这些结果将要么支持目前两种制剂无差异的观点。然而，如果发现有差异，这将引发未来探索各种制剂之间临床结局发生情况的试验。
Clinicaltrials.gov NCT04330872，于2020年4月2日注册。
