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适应性试验与冠状动脉疾病患者二级预防中的阿司匹林剂量

The ADAPTABLE Trial and Aspirin Dosing in Secondary Prevention for Patients with Coronary Artery Disease.

作者信息

Johnston Abigail, Jones W Schuyler, Hernandez Adrian F

机构信息

Duke Clinical Research Institute, Duke University School of Medicine, PO Box 17969, Durham, NC, 27715, USA.

Department of Medicine, Duke University School of Medicine, Durham, NC, USA.

出版信息

Curr Cardiol Rep. 2016 Aug;18(8):81. doi: 10.1007/s11886-016-0749-2.

Abstract

Coronary artery disease (CAD) is the underlying cause of death in one out of seven deaths in the USA. Aspirin therapy has been proven to decrease mortality and major adverse cardiovascular events in patients with CAD. Despite a plethora of studies showing the benefit of aspirin in secondary prevention of cardiovascular events, debate remains regarding the optimal dose due to relatively small studies that had disparate results when comparing patients taking different aspirin dosages. More recently, aspirin dosing has been thoroughly studied in the CAD population with concomitant therapy (such as P2Y12 inhibitors); however, patients in these studies were not randomized to aspirin dose. No randomized controlled trial has directly measured aspirin dosages in a population of patients with established coronary artery disease. In 2015, the Patient-Centered Outcomes Research Institute (PCORI) developed a network, called PCORnet, that includes patient-powered research networks (PPRN) and clinical data research networks (CDRN). The main objective of PCORnet is to conduct widely generalizable observational studies and clinical trials (including large, pragmatic clinical trials) at a low cost. The first clinical trial, called Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE), will randomly assign 20,000 subjects with established coronary heart disease to either low dose (81 mg) or high dose (325 mg) and should be able to finally answer which dosage of aspirin is best for patients with established cardiovascular disease.

摘要

冠状动脉疾病(CAD)是美国七分之一死亡病例的潜在死因。阿司匹林治疗已被证明可降低CAD患者的死亡率和主要不良心血管事件。尽管大量研究表明阿司匹林在心血管事件二级预防中有益,但由于比较不同阿司匹林剂量患者的研究规模相对较小且结果各异,关于最佳剂量的争论仍在继续。最近,在接受联合治疗(如P2Y12抑制剂)的CAD患者群体中对阿司匹林剂量进行了深入研究;然而,这些研究中的患者并未随机分配阿司匹林剂量。尚无随机对照试验直接测量确诊冠状动脉疾病患者群体中的阿司匹林剂量。2015年,以患者为中心的结果研究机构(PCORI)建立了一个名为PCORnet的网络,其中包括患者驱动研究网络(PPRN)和临床数据研究网络(CDRN)。PCORnet的主要目标是以低成本开展具有广泛普遍性的观察性研究和临床试验(包括大型实用临床试验)。首个临床试验名为“阿司匹林剂量:以患者为中心评估益处和长期有效性试验(ADAPTABLE)”,将把20000名确诊冠心病的受试者随机分为低剂量(81毫克)组或高剂量(325毫克)组,最终应该能够回答哪种阿司匹林剂量最适合确诊心血管疾病的患者。

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