Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglyceride and Impact on Global Health Outcomes
Short Study Name (acronym): AIM HIGH
Long Name: Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglyceride and Impact on Global Health Outcomes
Investigators (list PI first):
Jamehl Demons, MD
Jeff Williamson, MD
National Heart, Lung and Blood Institute (NHLBI)
Research questions or aims:
In patients with established vascular disease and atherogenic dyslipidemia, we plan to compare the efficacy and safety of statin monotherapy (with simvastatin) versus combination therapy (with extended-release niacin plus simvastatin), at comparable levels (<80 mg/dL [2.0 mmol/L]) of on-treatment LDL-C, in reducing the risk for the composite of coronary heart disease (CHD) death, nonfatal myocardial infarction (MI), non-hemorrhagic stroke (fatal or nonfatal), or hospitalization for high-risk non-ST-segment elevation (NSTE) acute coronary syndrome.
- To evaluate the effect of therapy on cardiovascular mortality
- To evaluate the effect of therapy on the composite endpoint of CHD death, non-fatal MI, or non-hemorrhagic stroke
- To evaluate the effect of therapy on total mortality
- To evaluate the effect of therapy on the composite endpoint of, or any individual component of the composite endpoint of, CHD death, non-fatal MI, non-hemorrhagic stroke (fatal or nonfatal), hospitalization for NSTE acute coronary syndrome, or any revascularization
- To evaluate the effect of therapy for preventing clinical events, as defined above, among patients meeting current criteria for metabolic syndrome as defined by the NCEP ATP III, or future criteria for metabolic syndrome, as they may evolve, or diabetes
- To assess the effects of statin monotherapy versus combination therapy on lipids and lipoproteins, including, but not limited to apoA-I, apoB, apoC-III, Lp(a), HDL subfractions/particle size, LDL size and subclass distribution, and their independent contribution to predicting outcomes
- To assess the effect of therapy on inflammatory markers such as C-reactive protein and fibrinogen, among others, and their independent contribution to predicting outcomes
- Target population: High-risk patients with established vascular disease (i.e., those who have a 10-year risk of an event of ³20%) who have atherogenic dyslipidemia (low HDL-C and high triglycerides). The vast majority of these patients will qualify for a diagnosis of metabolic syndrome.
Closed enrollment as of March 2010.
Total enrolled across US and Canada : 3400
Number enrolled at this site: 42.
Dates of enrollment:
Types of assessments and questionnaires:
Medical History, Demographics, Collection of past Medical Records for verification of established Cardiovascular Disease, QOL questionnaire. Physical Measurements including: BP readings, waist and hip measurements, ECG tracings.
Other data collected:
Fasting lipid panels, AST, Glucose, Creatinine , Uric Acid, Creatinine Kinase. Carotid MRI, HDL proteomics.
Study Website (if applicable): www.AIMHIGH-Heart.com
Coordinator Contact Info: