Hypotheses, design, and methods for the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial
Hypotheses, design, and methods for the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial
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DOI：
10.1016/j.amjcard.2006.02.023
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发表时间：
2006-06-19
影响因子：
2.8
通讯作者：
Orchard, Trevor J.
中科院分区：
文献类型：
--
作者：
Brooks, Maria Mori;Frye, Robert L.;Orchard, Trevor J.
旁路血管成形术血运重建研究2型糖尿病（巴里2D）是美国国立卫生研究院（NIH）申办的一项随机临床试验，旨在评价2型糖尿病和血管造影证实的稳定型冠状动脉疾病患者的治疗疗效。使用2 × 2析因设计，巴里2D比较了血运重建联合积极药物治疗与单独积极药物治疗;同时，巴里2D比较了2种血糖控制策略，胰岛素增敏与胰岛素供应。所有患者的目标是糖化血红蛋白值< 7.0%，并按照推荐的医疗指南统一控制高血压、血脂异常和肥胖。巴里2D的主要终点是通过意向治疗分析的全因5年死亡率，主要次要终点是死亡、心肌梗死和卒中的组合。在北美、南美和欧洲的49家临床中心共招募了2，368例患者。研究招募期为2001年1月至2005年3月，患者治疗和随访期预计至少延长至2007年5月。受试者在当地巴里2D临床研究中心接受治疗，前6个月每月一次，然后每3个月一次，直至研究结束。在巴里2D内，中央管理中心负责监督血糖、血脂水平、高血压和肥胖症的控制。随机临床试验收集了患者症状、临床测量、药物和临床事件的数据，以及来自血管造影、心电图、核负荷试验、血液和尿液标本以及相对经济成本的集中评估的数据。(c)2006年爱思唯尔公司All rights reserved.
The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) is a National Institutes of Health (NIH)-sponsored randomized clinical trial that evaluates treatment efficacy for patients with type 2 diabetes mellitus and angiographically documented stable coronary artery disease. Using a 2X2 factorial design, BARI 2D compares revascularization combined with aggressive medical treatment versus aggressive medical treatment alone; simultaneously, BARI 2D compares 2 glycemic control strategies, insulin sensitization versus insulin provision. All patients have goals of glycosylated hemoglobin values < 7.0% and uniform control of hypertension, dyslipidemia, and obesity following recommended medical guidelines. The primary' end point of BARI 2D is all-cause 5-year mortality analyzed by intention to treat, and the principal secondary end point is the combination of death, myocardial infarction, and stroke. A total of 2,368 patients have been enrolled at 49 clinical centers throughout North America, South America, and Europe. The study enrollment period was January 2001 through March 2005, and the patient treatment and follow-up phase is expected to extend at least through May 2007. Participants are treated at the local BARI 2D clinical sites on a monthly basis for the first 6 months and then every 3 months until the end of the study. Within BARI 2D, central management centers oversee the control of glycemia, plasma lipid levels, hypertension, and obesity. The randomized clinical trial collects data on patient symptoms, clinical measurements, medications, and clinical events as well as data from centralized evaluations of angiograms, electrocardiograms, nuclear stress tests, blood and urine specimens, and relative economic costs. (c) 2006 Elsevier Inc. All rights reserved.