ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES (ACCORD)

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 2型糖尿病患者死于心血管疾病(CVD)的比率比人口统计特征相似的非糖尿病人群高出两到四倍。他们还经历了非致命性心肌梗死和中风的增加。随着肥胖症在美国的日益流行，与2型糖尿病相关的心血管疾病预计在未来几十年将成为比现在更大的公共卫生挑战。事故率的预期增加将伴随着痛苦和资源利用的增加。尽管这一健康问题在北美人群中很重要，但关于强化控制血糖和其他心血管危险因素对糖尿病患者心血管事件发生率的影响，缺乏明确的数据。 控制糖尿病心血管风险的行动(ACCORD)试验的总体目标是通过测试针对2型糖尿病的三种互补的医疗治疗策略来应对这一挑战，以加强降低这种疾病中仍然很高的主要心血管疾病发病率和死亡率的选择。 该设计是一项随机、多中心、双2×2析因设计，涉及10,000名2型糖尿病患者。该试验旨在测试强化血糖控制、提高高密度脂蛋白胆固醇和降低甘油三酯的治疗(在良好的低密度脂蛋白和血糖控制的情况下)以及强化的血压控制(在良好的血糖控制的情况下)对主要心血管事件的影响。所有10,000名参与者都将参加最重要的血糖试验。此外，一项2×2试验还将解决5,800名参与者的血脂问题，另一项2×2试验将解决4,200名参与者的血压问题。 具体的三个基本符合假设如下。对于因现有临床或亚临床心血管疾病或心血管疾病危险因素而有心血管疾病(CVD)事件高危的2型糖尿病中老年患者： (1)与糖化血红蛋白7.5%为靶点的治疗策略相比，糖化血红蛋白6.0%的治疗策略是否可以降低心血管事件的发生率？ (2)与仅达到理想的低密度脂蛋白水平和血糖控制水平的治疗策略相比，在理想的低密度脂蛋白水平和良好的血糖控制的背景下，提高高密度脂蛋白-C和降低甘油三酯水平的治疗策略是否降低了心血管事件的发生率？ (3)在血糖控制良好的情况下，与以收缩压为140毫米汞为目标的治疗策略相比，收缩压(SBP)为120毫米汞的治疗策略是否能降低心血管事件的发生率？ 试验的主要结果衡量标准是首次发生重大心血管疾病事件，特别是非致命性心肌梗死、非致命性中风或心血管死亡。 ACCORD研究的目的是： +92%功率检测强化血糖控制与常规血糖控制相比15%的治疗效果， +90%的功率检测到通过降低低密度脂蛋白和贝特类药物来控制血脂的治疗效果比单独使用低密度脂蛋白胆固醇控制血脂的疗效高20%， +90%功率检测强化降压治疗效果较常规降压治疗效果提高20%。 次要假设包括在其他心血管结果、总死亡率、微血管结果、与健康相关的生活质量和成本效益方面的治疗差异。 10,000名参与者将在美国和加拿大7个临床中心网络内行政管理的大约60个临床地点接受治疗和跟踪治疗4至8年(大约平均5.6年)。征聘将分两个不连续的时期进行：第一个时期从2001年1月审判的先锋阶段开始，随后的时期从2002年5月(在审查先锋数据之后)开始，到2004年9月结束。后续行动定于2008年9月结束，初步结果将于2009年底公布。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Patients with type 2 diabetes mellitus die of cardiovascular disease (CVD) at rates two to four times higher than non-diabetic populations of similar demographic characteristics. They also experience increased rates of nonfatal myocardial infarction and stroke. With the growing prevalence of obesity in the United States, CVD associated with type 2 diabetes is expected to become an even greater public health challenge in the coming decades than it is now. Expected increases in event rates will be associated with a concomitant rise in suffering and resource utilization. Despite the importance of this health problem in the North American population, there is a lack of definitive data on the effects of intensive control of glycemia and other CVD risk factors on CVD event rates in diabetic patients. The overall goal of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is to address this challenge by testing three complementary medical treatment strategies for type 2 diabetes to enhance the options for reducing the still very high rate of major CVD morbidity and mortality in this disease. The design is a randomized, multicenter, double 2 X 2 factorial design in 10,000 patients with type 2 diabetes mellitus. The trial is designed to test the effects on major CVD events of intensive glycemia control, of treatment to increase HDL-cholesterol and lower triglycerides (in the context of good LDL-C and glycemia control), and of intensive blood pressure control (in the context of good glycemia control). All 10,000 participants will be in the overarching glycemia trial. In addition, one 2 X 2 trial will also address the lipid question in 5,800 of the participants and the other 2 X 2 trial will address the blood pressure question in 4,200 of the participants. The three specific primary ACCORD hypotheses are as follow. In middle-aged or older people with type 2 diabetes who are at high risk for having a cardiovascular disease (CVD) event because of existing clinical or subclinical CVD or CVD risk factors: (1) does a therapeutic strategy that targets a HbA1c of < 6.0% reduce the rate of CVD events compared to a strategy that targets a HbA1c of < 7.5% ? (2) does a therapeutic strategy that raises HDL-C and lowers triglyceride levels in the context of desirable levels of LDL-C and good glycemic control reduce the rate of CVD events compared to a strategy that only achieves desirable levels of LDL-C and glycemic control? (3) In the context of good glycemic control, does a therapeutic strategy that targets a systolic blood pressure (SBP) of < 120 mm Hg reduce the rate of CVD events compared to a strategy that targets a SBP of < 140 mm Hg? The primary outcome measure for the trial is the first occurrence of a major cardiovascular disease event, specifically nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. The ACCORD study is designed to have: + 92% power to detect a 15% treatment effect of intensive glycemic control compared with conventional glycemic control, + 90% power to detect a 20% treatment effect of lipid control through LDL-C lowering and fibrates compared with lipid control using LDL-C lowering alone, + 90% power to detect a 20% treatment effect of intensive blood pressure control compared with conventional blood pressure control. Secondary hypotheses include treatment differences in other cardiovascular outcomes, total mortality, microvascular outcomes, health-related quality of life, and cost-effectiveness. The 10,000 participants will be treated and followed for 4 to 8 years (approximate mean of 5.6 years) at approximately 60 Clinical Sites administratively located within 7 Clinical Center Networks in the United States and Canada. Recruitment will occur in two non-contiguous periods: an initial period beginning in January 2001 in the Vanguard Phase of the trial and then a subsequent period beginning in May 2002 (after review of the vanguard data) and ending in September 2004. Follow-up is scheduled to end in September 2008, with the primary results announced by the end of 2009.