Duke Clinical Research Institute, Durham, North Carolina.
Duke University Medical Center, Durham, North Carolina.
JAMA Cardiol. 2020 May 1;5(5):598-607. doi: 10.1001/jamacardio.2020.0116.
Determining the right dosage of aspirin for the secondary prevention treatment of atherosclerotic cardiovascular disease (ASCVD) remains an unanswered and critical question.
To report the rationale and design for a randomized clinical trial to determine the optimal dosage of aspirin to be used for secondary prevention of ASCVD, using an innovative research method.
DESIGN, SETTING, AND PARTICIPANTS: This pragmatic, open-label, patient-centered, randomized clinical trial is being conducted in 15 000 patients within the National Patient-Centered Clinical Research Network (PCORnet), a distributed research network of partners including clinical research networks, health plan research networks, and patient-powered research networks across the United States. Patients with established ASCVD treated in routine clinical practice within the network are eligible. Patient recruitment began in April 2016. Enrollment was completed in June 2019. Final follow-up is expected to be completed by June 2020.
Participants are randomized on a web platform in a 1:1 fashion to either 81 mg or 325 mg of aspirin daily.
The primary efficacy end point is the composite of all-cause mortality, hospitalization for nonfatal myocardial infarction, or hospitalization for a nonfatal stroke. The primary safety end point is hospitalization for major bleeding associated with a blood-product transfusion. End points are captured through regular queries of the health systems' common data model within the structure of PCORnet's distributed data environment.
As a pragmatic study and the first interventional trial conducted within the PCORnet electronic data infrastructure, this trial is testing several unique and innovative operational approaches that have the potential to disrupt and transform the conduct of future patient-centered randomized clinical trials by evaluating treatments integrated in clinical practice while at the same time determining the optimal dosage of aspirin for secondary prevention of ASCVD.
ClinicalTrials.gov Identifier: NCT02697916.
确定用于动脉粥样硬化性心血管疾病（ASCVD）二级预防治疗的阿司匹林的正确剂量仍然是一个悬而未决的关键问题。
报告一项随机临床试验的原理和设计，该试验使用创新的研究方法来确定用于 ASCVD 二级预防的最佳阿司匹林剂量。
设计、设置和参与者：这项实用的、开放性标签的、以患者为中心的随机临床试验正在国家以患者为中心的临床研究网络（PCORnet）中的 15000 名患者中进行，该网络是一个由合作伙伴组成的分布式研究网络，包括临床研究网络、健康计划研究网络和美国各地的患者驱动的研究网络。有资格参加的是在网络内常规临床实践中接受治疗的已确诊 ASCVD 的患者。患者招募于 2016 年 4 月开始。2019 年 6 月完成登记。预计最终随访将于 2020 年 6 月完成。
参与者通过网络平台以 1:1 的比例随机分配至每日 81mg 或 325mg 的阿司匹林。
复合终点是全因死亡率、非致死性心肌梗死住院或非致死性卒中住院。主要安全性终点是与输血相关的大出血住院。终点通过定期查询 PCORnet 分布式数据环境结构中的健康系统通用数据模型来捕获。
作为一项实用研究，也是在 PCORnet 电子数据基础设施中进行的第一项干预性试验，该试验正在测试几种独特和创新的操作方法，这些方法有可能通过评估整合在临床实践中的治疗方法，同时确定用于 ASCVD 二级预防的最佳阿司匹林剂量，从而改变未来以患者为中心的随机临床试验的进行方式。
ClinicalTrials.gov 标识符：NCT02697916。
