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

CLINICAL TRIAL: AIM-HIGH: ATHEROSCLEROSIS INTERVENTIONIN MATABOLIC SYNDROME WIT
临床试验:志存高远:代谢综合征 WIT 中的动脉粥样硬化干预
批准号:
8167013
负责人:
JOHN R CROUSE
金额:
$44.83万
依托单位国家:
美国
项目类别:
财政年份:
2010
资助国家:
美国
项目状态:
已结题
起止时间:
2010-03-01 至 2011-02-28

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中文摘要
翻译
该子项目是利用 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来源获得主要资金, 因此可以在其他CRISP条目中表示。列出的机构是 中心,不一定是研究者的机构。 AIM-HIGH是一项多中心、前瞻性、随机化、双盲、平行组、活性对照试验,比较辛伐他汀(他汀类药物单药治疗)与缓释烟酸加辛伐他汀(联合治疗)治疗已确诊血管疾病的高危患者(即,10年事件风险≥ 20%的患者)和致动脉粥样硬化性血脂异常(低HDL-C和高甘油三酯)。AIM-HIGH的假设是,在有记录的血管疾病和致动脉粥样硬化性血脂异常患者中,联合抗血脂异常治疗用作二级预防时,在减少长期临床事件方面优于他汀类药物单药治疗上级。 潜在合格的受试者必须符合以下一项或多项已确诊血管疾病的标准。记录的冠状动脉疾病(CAD)、记录的脑血管疾病或记录的症状性PAD。在3-5年随访期间,研究将在治疗中LDL-C水平相当的情况下比较他汀类药物单药治疗与联合治疗在致动脉粥样硬化性血脂异常(低HDL-C和高甘油三酯)血管疾病患者中的疗效和安全性,以降低临床事件或因高风险NSTE急性冠状动脉综合征住院的风险。
英文摘要
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).
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