AIM HIGH: Niacin Plus Statin to Prevent Vascular Events

志存高远：烟酸加他汀类药物预防血管事件

• 批准号: 6955771
• 负责人: BRUCE G BROWN
• 金额: $ 66.34万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-23 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6955771
• 关键词: blood chemistry; blood disorder chemotherapy; cardiovascular disorder prevention; cardiovascular disorder risk; clinical research; clinical trials; combination chemotherapy; cooperative study; coronary disorder; electrocardiography; human middle age (35-64); human subject; human therapy evaluation; hypercholesterolemia; longitudinal human study; low density lipoprotein; myocardial infarction; niacin; outcomes research; simvastatin; stroke

DESCRIPTION (provided by applicant): AIM-HIGH is a multicenter controlled clinical trial designed to test whether the drug combination extended release niacin plus simvastatin is superior to simvastatin alone, at comparable levels of in-treatment LDLcholesterol (LDL-C), for delaying the time to a first major cardiovascular (CV) disease outcome over a 4-year median follow-up in patients with atherogenic dyslipidemia. Prior clinical trials have found only 25-35% CV risk reduction using statin monotherapy (i.e., event rate 2/3 to 3/4 of placebo rate). The proposed study is needed to confirm whether statin-niacin combination therapy, designed to target a wider spectrum of dyslipidemic factors in addition to LDL-C, will provide a more substantial (>50%) reduction of CV events. Epidemiologic studies confirm the high prevalance of atherogenic dyslipidemia and its impact on CV event rates. Preliminary clinical trials suggest that targeting these factors with dylipidemic therapy will reduce CV events. The proposed study will enroll men and women >45 years old at high risk of recurrent CV events by virtue of having established CV disease together with the two dyslipidemic elements of metabolic syndrome - low HDL-cholesterol (HDL-C) [<=40 mg/dl] and high triglycerides (TG) [>=150 mg/dl]. The proposed study specifically aims to test this hypothesis for the primary composite clinical endpoint of CV death, nonfatal myocardial infarction (Ml), non-hemorrhagic stroke, or hospitalization for high-risk acute coronary syndrome with objective evidence of ischemia (troponin-positive or ST-segment deviation). A secondary endpoint is the composite of CV death, non-fatal Ml, or non-hemorrhagic stroke. The 3300-patient sample, to be recruited in 54 centers in US and Canada, will have >90% power for the primary endpoint, and up to 85% power to confirm a 29% risk reduction, relative to statin monotherapy, for the triple endpoint above. In summary, statins have little effect on HDL-C orTG, and only moderately reduce CV risk. AIM-HIGH is designed to confirm a substantially greater benefit from "complete" lipid therapy using statins plus niacin.

描述（由申请人提供）： AIM-HIGH是一项多中心对照临床试验，旨在测试药物组合延长释放烟酸加辛伐他汀是否仅优于辛伐他汀，在可比水平的LDL胆固醇（LDL-C）水平上，可以将时间推迟到第一次主要的心血管疾病（CV）疾病后果的患者，以延迟到4年中的患者，并将其延迟到4年的患者中。先前的临床试验发现，使用他汀类药物单药治疗（即，安慰剂率的2/3至3/4）仅发现25-35％的CV风险降低。拟议的研究需要确认他汀类药物组合组合疗法是否旨在针对更广泛的血脂症因素，除了LDL-C之外，还将提供更大的（> 50％）减少CV事件。 流行病学研究证实了动脉粥样硬化血脂异常的高流行及其对CV事件发生率的影响。初步的临床试验表明，针对这些因素靶向染色性疗法将减少简历事件。拟议的研究将通过建立CV疾病以及代谢综合征的两种血脂性元素 - 低HDL-胆固醇（HDL-C）[<= 40 mg/dl]和高触发液（TG）（TG）[> = 150 mg/dl] [<= 40 mg/dl] [<= 40 mg/dl] [<= 40 mg/dl] [<= 40 mg/dl] [<= 40 mg/dl]。拟议的研究专门旨在检验该假设，用于对CV死亡，非致命性心肌梗死（ML），非毛发性中风或住院治疗的主要复合临床终点，用于客观的急性冠状动脉综合征，具有缺血性（曲霉阳性或ST片段偏差）的客观证据。次要终点是CV死亡，非致命ML或非诊断中风的复合材料。将在美国和加拿大的54个中心招募的3300名患者样本将对主要终点的功率> 90％，并且在上述三重终点相对于他汀类药物单一疗法，可确认降低29％的风险。总而言之，他汀类药物对HDL-C ORTG的影响很小，只会降低简历风险。 AIM-HIGH旨在确认使用他汀类药物和烟酸的“完整”脂质疗法获得更大的好处。