AIM HIGH will be a randomized trial to evaluate a treatment strategy of increasing low levels of HDL-cholesterol (HDL-C = “good” cholesterol) and lowering elevated levels of triglycerides, in addition to lowering LDL-C (“bad” cholesterol) to reduce the risk of heart attack, stroke and acute coronary syndrome. 3,300 patients with established vascular disease and “atherogenic dyslipidemia” (i.e., low HDL-C and high triglycerides – another type of blood fat; see below for enrollment criteria) will be recruited from clinical sites in the US and Canada. Enrollment will begin in Fall, 2005. Follow-up will last for an average of 4 years.

The study will be the first large study to measure the independent effect of treating HDL-C and triglycerides with a combination of extended-release niacin (prescription Niaspan®) and simvastatin as compared to treatment with simvastatin alone in the prevention of heart disease. Simvastatin will be started at 40 mg/day and may be increased to achieve an LDL-C target of , ≤80 mg/dl. The study will include a large percentage of women (at least 30 percent), among whom cardiovascular disease is the number one cause of death.

This trial is sponsored by the National Heart, Lung, and Blood Institute (NIH, www.nhlbi.nih.gov) with supplemental funding from Kos Pharmaceuticals (www.KosPharm.com).

ENROLLMENT CRITERIA

Inclusion Criteria

• Established vascular disease defined as one or more of the following:
  • Coronary artery disease
  • Cerebrovascular disease or carotid disease
  • Peripheral Arterial Disease
• Dyslipidemia defined as untreated lipid profile of:
  • LDL-C ≤ 160 mg/dl untreated or off lipid therapy. (This upper limit is adjusted downward for anyone concurrently treated with statins such as Crestor®, Zocor®, or Lipitor®)
  • HDL-C ≤ 40 mg/dl for men and ≤ 50 mg/dl for women
  • Triglyceride ≥ 150 mg/dl and ≤ 400 mg/dl

Major Exclusion Criteria

• Coronary Artery Bypass Graft (CABG) surgery within 5 years prior to planned enrollment, unless there has been a recent episode of acute coronary syndrome {unstable angina with or without Percutaneous Coronary Intervention (PCI), stable for more than 4 weeks.}
• PCI {or documented unstable angina} within 4 weeks of planned enrollment
• Fasting glucose >180 mg/dL or hemoglobin A1C >9%. Patients with diabetes under better control may participate.
• Recent gout attack, or history of gout, with elevated uric acid (>7.0 mg/dl)

Please watch for further information at www.clinicaltrials.gov