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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

基本信息

批准号：
7842493
负责人：
JEFFREY Lynn PROBSTFIELD
金额：
$ 49.03万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-09-23 至 2013-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7842493
关键词：
Adult Apolipoproteins A Apolipoproteins B Apolipoproteins C Apoproteins Atherosclerosis Blood Glucose Blood Vessels Brain hemorrhage C-reactive protein Canada Cardiovascular Diseases Cardiovascular system Cause of Death Central obesity Cessation of life Cholesterol Clinical Clinical Trials Clinical Trials Design Combined Modality Therapy Controlled Clinical Trials Coronary Coronary heart disease Disease Disease Outcome Doctor of Philosophy Drug Combinations Dyslipidemias Economics Education Elements Enrollment Epidemiologic Studies Epidemiology Event Fasting Fibrinogen Future Gemfibrozil Goals Health Policy Healthcare Heart High Density Lipoprotein Cholesterol High Density Lipoproteins Hospitalization Hypertension Hypertriglyceridemia Individual Inflammatory Ischemia LDL Cholesterol Lipoproteins Lipids Lipoprotein (a)Lipoproteins Low-Density Lipoproteins Measurement Metabolic syndrome Myocardial Infarction NMR Spectroscopy Nicotinic Acids Non-Insulin-Dependent Diabetes Mellitus Obesity Outcome Particle Size Patients Pharmaceutical Preparations Placebos Plasma Population Prevalence Prevention Primary Prevention Principal Investigator Recording of previous events Recruitment Activity Recurrence Relative (related person)Research Personnel Residual state Risk Risk Factors Risk Reduction Sampling Simvastatin Stroke Study Subject Subgroup Testing Time Triglycerides Troponin Western World Woman acute coronary syndrome cardiovascular risk factor cerebrovascular conventional therapy design disability experience follow-up glycemic control high risk inflammatory marker meetings men mortality particle prevent programs response therapy design

项目摘要

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，旨在检测在治疗中LDL胆固醇（LDL-C）水平相当的情况下，烟酸缓释剂联合辛伐他汀在延迟致动脉粥样硬化性血脂异常患者至首次重大心血管（CV）疾病结局的时间方面是否上级辛伐他汀单药治疗，中位随访时间为4年。先前的临床试验发现，使用他汀类药物单药治疗仅使CV风险降低25-35%（即，事件发生率为安慰剂发生率的2/3至3/4）。需要拟定的研究来确认他汀类药物-烟酸联合治疗（旨在针对除LDL-C外的更广泛的血脂异常因素）是否能更显著（>50%）地减少CV事件。流行病学研究证实了致动脉粥样硬化性血脂异常的高患病率及其对CV事件发生率的影响。初步临床试验表明，针对这些因素进行血液病治疗将减少CV事件。拟议的研究将招募年龄>45岁的男性和女性，这些男性和女性由于已确定CV疾病以及代谢综合征的两种血脂异常因素-低HDL-胆固醇（HDL-C）[<=40 mg/dl]和高甘油三酯（TG）[>=150 mg/dl]而具有CV事件复发的高风险。拟定研究的具体目的是检验主要复合临床终点CV死亡、非致死性心肌梗死（MI）、非出血性卒中或因具有缺血客观证据（肌钙蛋白阳性或ST段偏移）的高危急性冠脉综合征住院治疗的假设。次要终点是CV死亡、非致死性MI或非出血性卒中的复合终点。在美国和加拿大的54个中心招募的3300名患者样本将具有>90%的主要终点把握度，并且高达85%的把握度证实相对于他汀类药物单药治疗，上述三重终点的风险降低29%。总之，他汀类药物对HDL-C或TG的影响很小，只能适度降低CV风险。AIM-HIGH旨在确认使用他汀类药物加烟酸的“完全”脂质治疗的显著更大益处。