BARI II: A TRIAL OF REVASC. & GLYCEMIC CONTROL IN NIDDM

BARI II：REVASC 的试用。

• 批准号: 6537498
• 负责人: KATHERINE M DETRE
• 金额: $ 790.9万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 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/6537498
• 关键词: angina pectoris; blood glucose; clinical research; cooperative study; coronary bypass; coronary disorder; diabetes mellitus therapy; fibrinolysis; heart disorder chemotherapy; heart revascularization; human subject; human therapy evaluation; insulin; insulin sensitivity /resistance; longitudinal human study; myocardial ischemia /hypoxia; noninsulin dependent diabetes mellitus; nonsurgical revascularization

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.

经修订的搭桥血管成形术重建术研究（BARI） II