AIM HIGH
Niacin Plus Statin to Prevent Vascular Events
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Status:
This study is currently recruiting participants.
Purpose:
To determine whether raising "good cholesterol" with a drug based on the vitamin niacin, while lowering "bad cholesterol" with a statin drug, can prevent more heart disease than the statin alone.
Interventions:
Niacin
Niacin is the organic compound with the formula HO2CC5H4N.
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Statin
The statins (or HMG-CoA reductase inhibitors) form a class of hypolipidemic drugs used to lower cholesterol levels in people with or at risk of cardiovascular disease.
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Year Started:
2005
Design:
Interventional, Prevention, Randomized, Double-Blind.
Inclusion Criteria
Men and women aged 45 and older with established vascular disease and atherogenic dyslipidemia; established vascular disease defined as one or more of the following: (1) documented coronary artery disease (CAD); (2) documented cerebrovascular or carotid disease; (3) documented symptomatic peripheral arterial disease (PAD); atherogenic dyslipidemia defined as: (1) LDL-C of less than or equal to 160 mg/dL (4.1 mmol/L); (2) HDL-C of less than or equal to 40 mg/dL (1.0 mmol/L) for men or less than or equal to 50 mg/dL (1.3 mmol/L) for women; (3) TG greater than or equal to 150 mg/dL (1.7 mmol/L) and less than or equal to 400 mg/dL (4.5 mmol/L); for patients entering the trial on a statin: (1) the upper limit for LDL-C is adjusted according to the specific statin and statin dose; (2) HDL-C of less than or equal to 42 mg/dL (1.1 mmol/L) for men or less than or equal to 53 mg/dL (1.4 mmol/L) for women; (3) TG greater than or equal to 125 mg/dL (1.4 mmol/L) and less than or equal to 400 mg/DL (4.5 mmol/L).
Exclusion Criteria
Coronary artery bypass graft (CABG) surgery within 5 years of planned enrollment (run-in phase); Percutaneous coronary intervention (PCI) within 4 weeks of planned enrollment (run-in phase); hospitalization for acute coronary syndrome and discharge within 4 weeks of planned enrollment (run-in phase); fasting glucose greater than 180 mg/dL (10 mmol/L) or hemoglobin A1C greater than 9%; for patients with diabetes, inability or refusal to use a glucometer for home monitoring of blood glucose; concomitant use of drugs with a high probability of increasing the risk for hepatotoxicity or myopathy, such as those predominantly metabolized by cytochrome P450 system 3A4, including but not limited to cyclosporine, gemfibrozil, fenofibrate, itraconazole, ketoconazole, HIV protease inhibitors, nefazodone, verapamil, amiodarone; lipid-lowering drugs (other than the investigational drugs) such as statins, bile-acid sequestrants, cholesterol absorption inhibitors (e.g., ezetimibe), fibrates or high-dose, antioxidant vitamins (vitamins C, E, or beta carotene) that can interfere with the HDL-raising effect of niacin.
Patient Involvement:
Patients will be randomized to either niacin/statin combination therapy or to statin therapy and followed for 4 years with blood levels.
Primary Outcome:
Composite end point of CHD death, nonfatal MI, ischemic stroke, or hospitalization for high-risk non-ST segment elevation acute coronary syndrome (measured at time to first occurrence of one of these events).
Secondary Outcome:
The trial will follow all living patients to a common termination date (approximately December 2010)
Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 1/5/2009
Reviewed on: 07/16/2009.
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