ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES (ACCORD)

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 2型糖尿病患者死于心血管疾病（CVD）的比率比具有类似人口统计学特征的非糖尿病人群高2至4倍。他们还经历非致命性心肌梗死和中风的发生率增加。随着肥胖在美国的日益流行，预计与2型糖尿病相关的CVD在未来几十年将成为比现在更大的公共卫生挑战。 事件发生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，但缺乏关于强化控制糖尿病和其他CVD危险因素对糖尿病患者CVD事件发生率的影响的确切数据。 控制糖尿病心血管风险行动（雅阁）试验的总体目标是通过测试2型糖尿病的三种补充药物治疗策略来应对这一挑战，以增加降低这种疾病中仍然非常高的主要CVD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，在10，000例2型糖尿病患者中进行。 该试验旨在测试强化血糖控制、治疗以增加HDL-胆固醇和降低甘油三酯（在良好的LDL-C和血糖控制的背景下）以及强化血压控制（在良好的血糖控制的背景下）对主要CVD事件的影响。 所有10，000名参与者都将参加总体试验。 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。 三个具体的主要雅阁假设如下。 在由于存在临床或亚临床CVD或CVD风险因素而处于心血管疾病（CVD）事件高风险的2型糖尿病中年或老年人中： （一） 与以HbA 1c < 7.5%为目标的治疗策略相比，以HbA 1c < 6.0%为目标的治疗策略是否降低了CVD事件的发生率？ （二） 与仅达到理想的LDL-C和血糖控制水平的策略相比，在理想的LDL-C水平和良好的血糖控制的背景下升高HDL-C和降低甘油三酯水平的治疗策略是否降低CVD事件的发生率？ （三） 在血糖控制良好的情况下，与收缩压< 140 mm Hg的治疗策略相比，收缩压< 120 mm Hg的治疗策略是否能降低CVD事件的发生率？ 该试验的主要结局指标是首次发生重大心血管疾病事件，特别是非致死性心肌梗死、非致死性卒中或心血管死亡。 雅阁研究旨在： + 92%的把握度检测强化血糖控制与常规血糖控制相比15%的治疗效果， + 90%的把握度检测到通过降低LDL-C和贝特类药物进行血脂控制与单独使用降低LDL-C进行血脂控制相比20%的治疗效果， + 90%的把握度检测强化血压控制与传统血压控制相比20%的治疗效果。 次要假设包括其他心血管结局、总死亡率、微血管结局、健康相关生活质量和成本效益的治疗差异。 10，000名受试者将在美国和加拿大7个临床中心网络内的约60个临床研究中心接受4 - 8年（平均约5.6年）的治疗和随访。 招募将在两个不连续的阶段进行：初始阶段从2001年1月开始，试验的先锋阶段，随后的阶段从2002年5月开始（审查先锋数据后），至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.