Niacin Plus Statin to Prevent Vascular Events
Condition: Cardiovascular Diseases; Heart Diseases; Cerebrovascular Accident; Coronary Disease; Atherosclerosis; Myocardial Infarction
MeSH terms: Stroke; Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Atherosclerosis; Coronary Disease; Infarction
Intervention: Extended release niacin; Simvastatin
Intervention description: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated; Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target
Intervention MeSH terms: Niacin; Simvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3414.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is 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.
    

Eligibility criteria:

        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 1 year 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