ACCORD (Action to Control Cardiovascular Risk in Diabetes)

ACCORD（控制糖尿病心血管风险的行动）

• 批准号: 8339773
• 负责人: EMILY Y CHEW
• 金额: $ 3.28万
• 依托单位: NATIONAL EYE INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8339773
• 关键词: Blood Glucose; Blood Pressure; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Confidence Intervals; Congestive Heart Failure; Coronary Arteriosclerosis; Coronary heart disease; Diabetes Mellitus; Diabetic Angiopathies; Diabetic Retinopathy; Dyslipidemias; Eye; Fenofibrate; Fundus; Fundus photography; Goals; Hemoglobin; High Density Lipoprotein Cholesterol; High Density Lipoproteins; Hospitalization; Hypertension; Hypotension; LDL Cholesterol Lipoproteins; Lipids; Low-Density Lipoproteins; Masks; Measurement; Medical; Myocardial Infarction; Non-Insulin-Dependent Diabetes Mellitus; Odds Ratio; Ophthalmic examination and evaluation; Outcome; Participant; Patients; Persons; Phase; Placebos; Protocols documentation; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Recruitment Activity; Risk; Sample Size; Schedule; Serum; Simvastatin; Stroke; Triglycerides; arm; blood pressure regulation; cardiovascular risk factor; conventional therapy; design; follow-up; glycemic control; mortality; primary outcome; secondary outcome; stereoscopic

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) is a randomized clinical trial with 3 components, determining the effects of blood glucose lowering, blood pressure lowering, and lowering of serum triglycerides plus raising serum high density lipoprotein cholesterol levels on cardiovascular disease (CVD) in patients with type 2 diabetes. 10,000 participants will be randomly assigned in equal numbers to two glycemic management treatment arms. An intensive treatment arm will aim to achieve and maintain hemoglobin A1C level < 6.0%. A conventional treatment arm will target an A1C range of 7.0-7.9% with an expected mean value of approximately 7.5%. 4,200 of these participants will simultaneously be randomized to one of two hypertension management protocols. The intensive treatment arm targets a systolic blood pressure (SBP) < 120 mmHg and the conventional treatment arm targets a SBP <140 mmHg. 5,800 dyslipidemic ACCORD participants (HDL < 40 mg/dl) will be randomly assigned in a double masked fashion to either a placebo or fenofibrate 160 mg daily for reduction of triglyceride levels and increase in high-density lipoprotein cholesterol levels, after low-density lipoprotein cholesterol has been lowered with statin therapy (simvastatin 20 mg daily) to target LDL levels of approximately 100 mg/dl or lower. The primary endpoint of the ACCORD Trial is death from cardiovascular causes, non-fatal myocardial infarction and non-fatal stroke. Secondary outcomes include: the combination of the primary outcome plus any revascularization for coronary artery disease plus hospitalization for congestive heart failure; total mortality, cardiovascular mortality; any one of the specific coronary heart disease endpoints noted above, and fatal and non-fatal strokes. Other microvascular complications were also assessed in this study. An ancillary eye study was designed to evaluate the effects of these medical treatments on diabetic retinopathy within the ACCORD Trial. The ACCORD Eye Study consists of 2 eye exams with fundus photography of 7 stereoscopic fields, scheduled for baseline and year 4 of follow-up. The projected sample size is 4065 patients. The main ACCORD Trial, which follows the Vanguard Phase, recruited and randomizes participantss from February 2003 through June 2005. The ACCORD Eye Study showed that intensive glycemic control and intensive lipid therapy with fenofibrate and a statin reduced the risk of progression of diabetic retinopathy. At 4 years, the rates of progression of diabetic retinopathy were 7.3% with intensive glycemia treatment, versus 10.4% with standard therapy (adjusted odds ratio, 0.67; 95% confidence interval CI, 0.51 to 0.87; P = 0.003); 6.5% with fenofibrate for intensive dyslipidemia therapy, versus 10.2% with placebo (adjusted odds ratio, 0.60; 95% CI, 0.42 to 0.87; P = 0.006); and 10.4% with intensive blood-pressure therapy, versus 8.8% with standard therapy (adjusted odds ratio: 1.23; 95% CI, 0.84 to 1.79; P = 0.29).

控制糖尿病中心血管风险（ACCE）的动作是一项随机临床试验，具有3个成分，确定了血糖降低，血压降低以及降低血清甘油三酸酯的影响以及血清高密度脂蛋白胆固醇水平对心血管疾病（CVD）的影响。 10,000名参与者将以同等数量的随机分配，而两个血糖管理治疗组。密集的治疗臂将 旨在实现和维持血红蛋白A1C水平<6.0％。常规治疗组的目标范围为7.0-7.9％，预期平均值约为7.5％。 这些参与者中有4,200名将同时将其随机分为两个高血压管理方案之一。强化治疗组的靶向收缩压（SBP）<120 mmHg，常规治疗组的靶向SBP <140 mmHg。 5,800名血脂学协定参与者（HDL <40 mg/dl）将是随机的 以双蒙面的方式分配给安慰剂或160毫克非诺贝特 降低甘油三酸酯水平并增加高密度脂蛋白胆固醇水平， 在低密度脂蛋白胆固醇后，他汀类药物疗法降低了 （辛伐他汀每天20 mg）靶向大约100 mg/dl或更低的LDL水平。 协议试验的主要终点是死于心血管原因， 非致命性心肌梗塞和非致命性中风。次要结果包括： 主要结局以及冠状动脉的任何血运重建 疾病加上充血性心力衰竭的住院；总死亡率，心血管 死亡;上述特定的冠心病终点中的任何一个，致命 和非致命性中风。还评估了其他微血管并发症 学习。一项辅助眼研究旨在评估这些药物治疗对统一试验中糖尿病性视网膜病的影响。 Accord Eye研究由2次眼科检查和7个立体田地的眼底摄影组成，该摄影计划用于后续的基线和后续第4年。预计样本量为4065例。在Vanguard阶段之后的主要协议试验从2003年2月到2005年6月招募并随机招募了参与者。协定眼研究表明，密集的血糖控制和强化脂质疗法具有非诺贝特，而他汀类药物降低了糖尿病性视网膜病的进展的风险。 在4年时，糖尿病性视网膜病的进展率为7.3％ 血糖治疗，与标准治疗的10.4％相比10.4％（调整后比值比，0.67； 95％置信区间CI，0.51至0.87； p = 0.003）; 6.5％的非诺贝特型 血脂血症治疗，安慰剂的疗法为10.2％（调整后比值比，0.60； 95％CI，0.42至0.87; p = 0.006）;并且有10.4％的血压疗法， 标准治疗（调整后的比值比：1.23; 95％CI，0.84至1.79）与8.8％相比8.8％； p = 0.29）。