Niacin Plus Statin to Prevent Vascular Events

Stopped early · Phase 3

Conditions studied: Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Coronary Disease, Atherosclerosis, Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT00120289

Run by

Axio Research. LLC

People needed

3414

Starts

2005-09-01

Expected to finish

2012-12-01

Last updated by the study team

2016-04-06

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• Clinical Research Consultants, Inc. — Hoover, Alabama, United States
• Carl T. Hayden VAMC Phoenix Medical Service — Pheonix, Arizona, United States
• Cardiovascular Consultants Ltd — Phoenix, Arizona, United States
• Diabetes Center of Excellence — Phoenix, Arizona, United States
• Tucson Clinical Research (Eastside Site) — Tucson, Arizona, United States
• Tucson Clinical Research (Northwest Site) — Tucson, Arizona, United States
• University of Arkansas — Little Rock, Arkansas, United States
• Providence Saint Joseph Medical Center — Burbank, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• Providence Holy Cross Medical Center — Mission Hills, California, United States
• Christiana Care Health Services — Newark, Delaware, United States
• University of Miami — Miami, Florida, United States
• Heart & Vascular Research Center — Sarasota, Florida, United States
• James A. Haley Veteran's Hospital — Tampa, Florida, United States
• Idaho State University — Pocatello, Idaho, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• Iowa Heart Center, P.C. — Des Moines, Iowa, United States
• Lipid Research Clinic, University of Iowa — Iowa City, Iowa, United States
• Maine Center for Lipids & Cardiovascular Health — Scarborough, Maine, United States
• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Pentucket Medical Associates — Haverhill, Massachusetts, United States
• Veterans Affairs Health System of Ann Arbor, Michigan — Ann Arbor, Michigan, United States
• Cardiovascular Associates, P.C. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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