BARI II - FIBRINOLYSIS AND COAGULATION CORE

BARI II - 纤溶和凝血核心

• 批准号: 6891903
• 负责人: BURTON E SOBEL
• 金额: $ 56.79万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-15 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6891903
• 关键词: biomedical facility; blood coagulation; blood glucose; clinical research; cooperative study; coronary bypass; diabetes mellitus therapy; fibrinolysis; heart disorder chemotherapy; heart revascularization; human subject; human therapy evaluation; insulin sensitivity /resistance; myocardial ischemia /hypoxia; noninsulin dependent diabetes mellitus

The revised Bypass Angioplasty Revascularization Investigation (BARI) II study proposes to evaluate treatments for Type 2 diabetic patients with angiographically proven coronary artery disease and stable angina or ischemia. For this rapidly growing patient population with very poor prognosis and quality of life, revascularization has been less beneficial than in nondiabetics. Using a factorial design, BARI II will compare revascularization combined with aggressive medical anti-ischemia treatment to aggressive medical anti-ischemia treatment alone; simultaneously, BARI II will compare two glycemic control strategies, insulin sensitization versus insulin provision. All patients will have target HbA1c values < 7.5%, and uniform control of hypertension, dyslipidemia and obesity following recommended guidelines. A total of 2,600 patients will be recruited, randomized, treated, and followed at 30 clinical centers. Five-year mortality will be the primary endpoint analyzed by intention-to-treat. The Coordinating Center (CC) will assume responsibility for overall trial operations including clinical site selection, data management using an Internet system, and statistical analysis. Within the CC will be operational units for the management of diabetes control, lipids and hypertension. Detailed data on potential mechanisms of macrovascular events will be collected with centralized evaluations of ECGs, lipids and HbA1c levels. A fibrinolysis core laboratory will explore the effect of glycemic control strategy on the progression and mechanism of vasculopathy, including changes in PAI-1 activity and gene expression. The investigators will evaluate the relative economic costs associated with revascularization approaches and diabetes control (Separate application for the ECG Core, the Fibrinolysis Core and the Economics Core complement this lead application). This 7-year application includes a 6-month protocol finalization phase, 2 years of patient recruitment and an additional 4.5 years of follow-up. BARI II aims to answer critical scientific questions regarding treatment efficacy in Type 2 diabetic patients with stable CAD. The investigators further expect that this collaborative effort will translate into a new practical clinical paradigm that will be used for treatment of Type II diabetic patients.

修订后的旁路血管成形术血运重建研究（BARI）II研究 建议评估2型糖尿病患者的治疗 血管造影证明的冠状动脉疾病和稳定的心绞痛或缺血。 对于这个快速增长的患者人群，预后较差， 生活质量，血运重建比在 非糖尿病。使用阶乘设计，Bari II将比较血运重建 结合积极的医学抗离散治疗与积极的医疗 仅抗离血治疗；同时，Bari II将比较两个 血糖控制策略，胰岛素敏化与胰岛素提供。 所有患者的目标HBA1C值<7.5％，并且对 遵循建议的指南，高血压，血脂异常和肥胖症。 总共将招募，随机，治疗和遵循2600名患者 在30个临床中心。 五年死亡率将是主要终点 通过意向性治疗分析。 协调中心（CC）将假设 负责整体试验操作，包括临床现场选择， 使用Internet系统和统计分析的数据管理。 之内 CC将是用于管理糖尿病控制的运营单位， 脂质和高血压。 有关潜在机制的详细数据 大血管事件将通过对ECG的集中评估收集 脂质和HBA1C水平。 纤维蛋白溶解核心实验室将探索 血糖控制策略对进展和机制的影响 血管病，包括PAI-1活性和基因表达的变化。 这 调查人员将评估与 血运重建方法和糖尿病控制（单独应用 ECG核心，纤维蛋白溶解核心和经济学核心补充了这一点 线索应用程序）。 该7年申请包括一个6个月的协议 最终确定阶段，2年的患者招募和4。5年 随访。 Bari II旨在回答有关治疗的关键科学问题 稳定CAD的2型糖尿病患者的功效。 调查人员 进一步期望这种协作努力将转化为新的 实用的临床范式将用于治疗II型 糖尿病患者。