CLINICAL TRIAL: AIM-HIGH: ATHEROSCLEROSIS INTERVENTIONIN MATABOLIC SYNDROME WIT

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。 AIM-HIGH是一项多中心、前瞻性、随机、双盲、平行分组的积极比较试验，研究辛伐他汀(他汀类药物单一疗法)与缓释型烟酸加辛伐他汀(联合疗法)在已有血管疾病(即那些有10年发病风险=20%)和致动脉粥样硬化性血脂异常(低高密度脂蛋白胆固醇和高甘油三酯)的高危患者中的作用。AIM-HIGH的假设是，联合抗血脂治疗在用于二级预防时将优于单独使用他汀类药物作为二级预防措施，以减少有文献记载的血管疾病和动脉粥样硬化性血脂异常患者的长期临床事件。 可能符合条件的参与者必须符合以下一项或多项已确定的血管疾病标准。有记录的冠状动脉疾病(CAD)、有记录的脑血管疾病或有症状的PAD。在3-5年的随访中，这项研究将比较他汀类药物单独治疗和在同等水平的正在治疗的低密度脂蛋白水平下联合治疗的疗效和安全性，以降低动脉粥样硬化性血脂异常(低高密度脂蛋白胆固醇和高甘油三酯)的血管疾病患者的临床事件或住院风险(高风险NSTE急性冠脉综合征)。

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. AIM-HIGH is a multicenter, prospective, randomized, double-blind, parallel-group, active comparator trial of simvastatin (statin monotherapy) versus extended-release niacin plus simvastatin (combination therapy) in high-risk patients with established vascular disease (i.e., those who have a 10-year risk of an event of >=20%) and atherogenic dyslipidemia (low HDL-C and high triglycerides). The hypothesis of AIM-HIGH is that combination anti-dyslipidemic therapy will be superior to statin monotherapy alone when used as secondary prevention in reducing long-term clinical events in patients with documented vascular disease and atherogenic dyslipidemia. Potentially eligible participants must meet one or more of the following criteria for established vascular disease. Documented coronary artery disease (CAD), documented cerebrovascular disease, or documented symptomatic PAD. During a 3-5 year follow-up, the study will compare efficacy and safety of statin monotherapy versus combination therapy at comparable levels of on-treatment LDL-C, to reduce the risk for clinical events or hospitalization for high-risk NSTE acute coronary syndrome) in vascular disease patients with atherogenic dyslipidemia (low HDL-C and high triglycerides).