ACCORD

符合

• 批准号: 7902378
• 负责人: HERTZEL C GERSTEIN
• 金额: $ 344.07万
• 依托单位: MCMASTER UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7902378
• 关键词: ACCORD

ACCORD Trial Purpose and Design (June 30, 2006). 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 10,251 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 10,251 participants will be in the overarching glycemia trial. In addition, one 2 X 2 trial will also address the lipid question in 5,518 of the participants and the other 2 X 2 trial will address the blood pressure question in 4,733 of the participants. The 10,251 participants will be treated and followed for about 4 to 8 years (approximate mean of 5.6 years) at 77 Clinical Sites administratively located within 7 Clinical Center Networks in the United States and Canada. Recruitment occurred in two non-contiguous periods: an initial period that began in January 2001 for the Vanguard Phase of the trial (during which 1174 participants were randomized) and then a subsequent period beginning in January 2003 and ending in October 2005. Follow-up is scheduled to end in June 2009, with the primary results announced in early 2010. Additional information can be found at www.accordtrial.org. ACCORD Trial Update, February 6, 2008: "For Safety, NHLBI Changes Intensive Blood Sugar Treatment Strategy in Clinical Trial of Diabetes and Cardiovascular Disease." The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped one treatment within a large, ongoing North American clinical trial of diabetes and cardiovascular disease 18 months early due to safety concerns after review of available data, although the study will continue. In this trial of adults with type 2 diabetes at especially high risk for heart attack and stroke, the medical strategy to intensively lower blood glucose (sugar) below current recommendations increased the risk of death compared with a less-intensive standard treatment strategy. Study participants receiving intensive blood glucose lowering treatment will now receive the less-intensive standard treatment. The ACCORD (Action to Control Cardiovascular Risk in Diabetes) study enrolled 10,251 participants. Of these, 257 in the intensive treatment group have died, compared with 203 within the standard treatment group. This is a difference of 54 deaths, or 3 per 1,000 participants each year, over an average of almost four years of treatment. The death rates in both groups were lower than seen in similar populations in other studies. Additional information can be found at: http://www.nhlbi.nih.gov/health/prof/heart/other/accord/

协定试验目的和设计（2006年6月30日）。 2型糖尿病的患者因心血管疾病（CVD）死亡，比相似人口统计学特征的非糖尿病人群高两到四倍。他们还经历了非致命性心肌梗塞和中风的率提高。随着美国肥胖症的日益普遍性，与2型糖尿病相关的CVD预计将在未来几十年中成为更大的公共卫生挑战。事件率的预期增加将与痛苦和资源利用率的同时增加。尽管这种健康问题在北美人口中很重要，但缺乏有关血糖控制和其他CVD危险因素对糖尿病患者CVD事件发生率的严格数据的确切数据。控制糖尿病中心血管风险的行动的总体目标是通过测试2型2型糖尿病的三种补充医疗治疗策略来应对这一挑战，以增强降低这种疾病中主要CVD发病率和死亡率仍然很高的选择。该设计是10,251例2型糖尿病患者的随机，多中心，双2 x 2阶乘设计。该试验旨在测试对强烈血糖控制的主要CVD事件，治疗的影响，以增加HDL-胆固醇和较低的甘油三酸酯（在良好的LDL-C和Glycemia Control的背景下）以及强度的血压控制（在良好的血糖控制的背景下）。所有10,251名参与者将参加总体血糖试验。此外，一个2 x 2试验还将解决5,518名参与者的脂质问题，而其他2 x 2试验将解决4,733名参与者的血压问题。 10,251名参与者将在美国和加拿大的77个临床中心网络内的77个临床站点进行治疗，并遵循约4至8年（大约平均5。6年）。招聘发生在两个非连续时期：2001年1月开始的初始阶段，该阶段开始了该试验的先锋阶段（在此期间有1174个参与者被随机分配），然后从2003年1月开始的随后阶段开始，并于2005年10月结束。计划于2009年6月结束，并在2010年初宣布了主要结果。 协定试验更新，2008年2月6日：“为了安全性，NHLBI在糖尿病和心血管疾病的临床试验中改变了强化血糖治疗策略。”美国国立卫生研究院的国家心脏，肺和血液研究所（NHLBI）在一项大型的，正在进行的北美糖尿病和心血管疾病的临床试验中，由于对可用数据的审查后的安全问题，提前18个月停止了一种治疗，尽管该研究将继续进行。在这项2型糖尿病的成年人的试验中，心脏病发作和中风风险尤其高，与当前建议相比，与当前建议相比，强烈降低血糖（糖）的医疗策略与不太强大的标准治疗策略相比增加了死亡的风险。接受强化血糖降低治疗的研究参与者现在将接受较不密集的标准治疗方法。协定（控制糖尿病中心血管风险的行动）研究招募了10,251名参与者。其中，强化治疗组中有257个死亡，而标准治疗组中有203个。这是54例死亡的差异，每年为每年1,000名参与者3例，平均差异近四年。在其他研究中，两组的死亡率均低于相似人群中的死亡率。其他信息可以在以下网址找到：http：//www.nhlbi.nih.gov/health/prof/heart/heart/other/accord/