ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES (ACCORD) TRIAL

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。具体的三个基本一致假设如下。在患有2型糖尿病的中老年患者中，由于现有的临床或亚临床心血管疾病或心血管疾病风险因素，他们发生心血管疾病(CVD)事件的风险很高：1)以HbA1c为目标的6.0%的治疗策略是否比目标HbA1c为7.0%至7.9%(除达到7.5%的中位数水平外)的治疗策略更能降低心血管事件的发生率？2)在血糖控制良好的情况下，与只使用他汀类药物治疗低密度脂蛋白-C的治疗策略相比，使用贝特酯提高低密度脂蛋白/降低甘油三酯水平并使用他汀类药物治疗低密度脂蛋白-C的治疗策略是否降低了心血管事件的发生率？3)在良好的血糖控制背景下，与目标收缩压为140毫米汞的治疗策略相比，目标为120毫米汞的收缩压的治疗策略是否降低了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，特别是非早产儿心肌梗死、非致命性中风或心血管死亡。该设计是一项随机、多中心、双2X2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、提高低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胆固醇和血糖控制的背景下)和强化血压控制(在良好的血糖控制的背景下)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2X2试验还将解决5800名参与者的血脂问题，另一项2X2试验将解决4200名参与者的血压问题。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)。招募工作将分两个不连续的阶段进行：第一阶段从2001年1月开始，试验的先锋阶段(在此期间随机抽取了1184名参与者)，然后是第二阶段，从2003年1月开始，到2005年6月结束。后续行动计划于2009年6月结束，初步结果将于2010年初公布。

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. The three specific primary ACCORD hypotheses are as follows. 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 HbA1c of < 6.0% reduce the rate of CVD events more than a strategy that targets a HbA1c of 7.0% to 7.9% (with the exception of achieving a median level of 7.5%)?; 2) in the context of good glycemic control, does a therapeutic strategy that uses a fibrate to raise LDL-C/lower triglyceride levels and uses a statin for treatment of LDL-C reduce the rate of CVD events compared to a strategy that only uses a statin for treatment of LDL-C?; 3) in the context of good glycemic control, does a therapeutic strategy that targets a systolic blood pressure (SBP) of <120mm Hg reduce the rate of CVD events compared to a strategy that targets a SBP of <140mm Hg? The primary outcome measure for the trial is the first occurrence of a major cardiovascular disease event, specifically nonf-atal myocardial infarction, non-fatal stroke, or cardiovascular death. The design is a randomized, multicenter, double 2X2 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 LDL-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 2X2 trial will also address the lipid question in 5,800 of the participants and the other 2X2 trial will address the blood pressure question in 4,200 of the participants. 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 that began in January, 2001, for the Vanguard Phase of the trial (during which 1184 participants were randomized) and then a subsequent period beginning in January, 2003, and ending in June, 2005. Follow-up is scheduled to end in June, 2009, with the primary results announced in early 2010.