Niacin Plus Statin to Prevent Vascular Events

This study has been terminated.
(AIM-HIGH was stopped on the recommendation of the DSMB because of lack of efficacy of niacin in preventing primary outcome events.)
Sponsor:
Collaborators:
Abbott
Information provided by (Responsible Party):
Ruth McBride, Axio Research. LLC
ClinicalTrials.gov Identifier:
NCT00120289
First received: July 6, 2005
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Heart Diseases
Cerebrovascular Accident
Coronary Disease
Atherosclerosis
Myocardial Infarction
Drug: Extended release niacin
Drug: Simvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: AIM HIGH: Niacin Plus Statin to Prevent Vascular Events

Resource links provided by NLM:


Further study details as provided by Axio Research. LLC:

Primary Outcome Measures:
  • Composite end point of CHD death, nonfatal MI, ischemic stroke, hospitalization for non-ST segment elevation acute coronary syndrome (ACS), or symptom-driven coronary or cerebral revascularization [ Time Frame: Time to first event ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Composite endpoint of CHD death, non-fatal MI, high-risk ACS or ischemic stroke [ Time Frame: Time to first event ] [ Designated as safety issue: Yes ]
  • Composite endpoint of CHD death, non-fatal MI, or ischemic stroke [ Time Frame: Time to first event ] [ Designated as safety issue: Yes ]
  • Cardiovascular mortality [ Time Frame: Time to event ] [ Designated as safety issue: Yes ]

Enrollment: 3414
Study Start Date: September 2005
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Extended release niacin plus simvastatin
Drug: Extended release niacin
2,000 mg/day or 1,500 mg/day if higher dose not tolerated
Drug: Simvastatin
Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target
Active Comparator: 2
Simvastatin alone
Drug: Simvastatin
Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120289

  Hide Study Locations
Locations
United States, Alabama
Cardiovascular Associates, P.C.
Birmingham, Alabama, United States, 35213
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
Clinical Research Consultants, Inc.
Hoover, Alabama, United States, 35216
United States, Arizona
Carl T. Hayden VAMC Phoenix Medical Service
Pheonix, Arizona, United States, 85012
Diabetes Center of Excellence
Phoenix, Arizona, United States, 85016
Cardiovascular Consultants Ltd
Phoenix, Arizona, United States, 85015
Tucson Clinical Research (Eastside Site)
Tucson, Arizona, United States, 85712
Tucson Clinical Research (Northwest Site)
Tucson, Arizona, United States, 85741
United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
Providence Holy Cross Medical Center
Mission Hills, California, United States, 91345
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Heart & Vascular Research Center
Sarasota, Florida, United States, 34239
James A. Haley Veteran's Hospital
Tampa, Florida, United States, 33612
United States, Idaho
Idaho State University
Pocatello, Idaho, United States, 83201
United States, Indiana
Parkview Research Center
Fort Wayne, Indiana, United States, 46805
United States, Iowa
Iowa Heart Center, P.C.
Des Moines, Iowa, United States, 50314
Lipid Research Clinic, University of Iowa
Iowa City, Iowa, United States, 52240
United States, Maine
Maine Center for Lipids & Cardiovascular Health
Scarborough, Maine, United States, 04074
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Pentucket Medical Associates
Haverhill, Massachusetts, United States, 01830
United States, Michigan
Veterans Affairs Health System of Ann Arbor, Michigan
Ann Arbor, Michigan, United States, 48105
Grunberger Diabetes Institute
Bloomfield Hills, Michigan, United States, 48302
United States, Minnesota
HealthPartners Riverside Clinic
Minneapolis, Minnesota, United States, 55454
Berman Center for Outcomes and Clinical Research
Minneapolis, Minnesota, United States, 55404
Mayo Clinic
Rochester, Minnesota, United States, 55905
Phalen Village Clinic
St. Paul, Minnesota, United States, 55106
University of Minnesota
Twin Cities, Minnesota, United States, 55414
United States, Mississippi
G.V. (Sonny) Montgomery VAMC
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63104
United States, Nebraska
Alegent Health Heart & Vascular Specialists
Papillion, Nebraska, United States, 68046
United States, New Jersey
Cooper Clinical Trials Center
Cherry Hill, New Jersey, United States, 08034
Cardiovascular Associates of the Delaware Valley
Elmer, New Jersey, United States, 08318
UMDNJ -Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
New Mexico VA Healthcare Systems
Albuquerque, New Mexico, United States, 87108
United States, New York
Kaleida Health/Diabetes Center
Buffalo, New York, United States, 14209
Mid Valley Cardiology
Kingston, New York, United States, 12401
Columbia University
New York, New York, United States, 10032
VA New York Harbor Healthcare System
New York, New York, United States, 10010
Syracuse Preventive Cardiology
Syracuse, New York, United States, 13202
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University - Geriatrics/Gerontology
Greensboro, North Carolina, United States, 27157
Wake Forest University Health Sciences - Department of Cardiology
Winston-Salem, North Carolina, United States, 27157
Wake Forest University School of Medicine - Internal Medicine/Endocrinology
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States, 45219
St Vincent Charity Hospital - The Center for Vascular Health
Cleveland, Ohio, United States, 44115
North Ohio Research, Ltd.
Sandusky, Ohio, United States, 44870
United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, United States, 19148
Pennsylvania Cardiology Associates
Philadelphia, Pennsylvania, United States, 19106
United States, Rhode Island
Women's Cardiac Center at The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Internal Medicine Associates of Greenville
Greenville, South Carolina, United States, 29607
United States, Tennessee
VAMC Memphis - Hypertension/Lipid Research Clinic
Memphis, Tennessee, United States, 38104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
Kelsey Research Foundation
Houston, Texas, United States, 77005
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
United States, Virginia
University of Virginia - UVA Cardiology
Charlottesville, Virginia, United States, 22908
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
United States, Washington
University of Washington, Coronary Atherosclerosis Research Lab
Seattle, Washington, United States, 98105
University of Washington, Northwest Lipid Research Center
Seattle, Washington, United States, 98104
VA Cardiology Research
Seattle, Washington, United States, 98108
Washington State University
Spokane, Washington, United States, 99202
United States, Wisconsin
CARE Foundation, Inc.
Wausau, Wisconsin, United States, 54401
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Heart Health Institute
Calgary, Alberta, Canada, T2E 7C5
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Vancouver Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Victoria Heart Institute
Victoria, British Columbia, Canada, V8R 4R2
Canada, Manitoba
Health Sciences Center, Diabetes Research Group
Winnipeg, Manitoba, Canada, R3E 3R4
Canada, New Brunswick
New Brunswick Heart Center
St John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A6
Cardiology Associates VRH
Kentville, Nova Scotia, Canada, B4N 5E3
Canada, Ontario
Cambridge Cardiac Care Center
Cambridge, Ontario, Canada, N1R 6V6
McConnell Medical Center
Cornwall, Ontario, Canada, K6H 4M4
Hamilton Health Sciences - General Site
Hamilton, Ontario, Canada, L8L 2X2
LHSC University Hospital
London, Ontario, Canada, N6A 5A5
Newmarket Cardiology Research Group
Newmarket, Ontario, Canada, L3Y 8C3
Sudbury Cardiovascular Research
Sudbury, Ontario, Canada, P3E 2N8
St. Michael's Hospital Health Centre
Toronto, Ontario, Canada, M5C 2T2
Canada, Quebec
Clinique de Cardiologie de Lévis
Lévis, Quebec, Canada, G6V 4Z5
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Clinique des maladies lipidiques de Québec
Québec, Quebec, Canada, G1V 4M6
CSSS Beauce
St-Georges de Beauce, Quebec, Canada, G5Y 4T8
CSSS du Sud de Lanaudière - Hôpital Pierre-Le Gardeur
Terrebonne, Quebec, Canada, J6V 2H2
Canada
Recherches Clinicar
Quebec, Canada, G1J 1Z6
Sponsors and Collaborators
Axio Research. LLC
Abbott
Investigators
Study Director: Ruth McBride Axio Research Corporation
Principal Investigator: William E. Boden, MD Samuel S. Stratton VA Medical Center
Principal Investigator: Jeffrey Probstfield, MD University of Washington
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ruth McBride, Co-Director, Coordinating Center, Axio Research. LLC
ClinicalTrials.gov Identifier: NCT00120289     History of Changes
Other Study ID Numbers: 226, U01HL081649, U01HL081616, U01 HL81616, U01 HL81649
Study First Received: July 6, 2005
Last Updated: January 9, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Infarction
Heart Diseases
Atherosclerosis
Arteriosclerosis
Coronary Disease
Coronary Artery Disease
Cerebral Infarction
Stroke
Myocardial Ischemia
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Arterial Occlusive Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Simvastatin
Niacin
Nicotinic Acids
Niacinamide
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014