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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:
Axio Research. LLC
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Abbott
Information provided by (Responsible Party):
Ruth McBride, Axio Research. LLC
ClinicalTrials.gov Identifier:
NCT00120289
First received: July 6, 2005
Last updated: March 8, 2016
Last verified: March 2016
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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 Ruth McBride, 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 measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months. ]
Secondary Outcome Measures:
- Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke [ Time Frame: Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months ]
- Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke [ Time Frame: Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months ]
- Cardiovascular Mortality [ Time Frame: Time to first event measured from date of randomization through last follow-up visit (common termination), for an average of 36 months follow-up, maximum 66 months. ]
| 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: Combination Therapy
Extended release niacin plus simvastatin
|
Drug: Extended release niacin
2,000 mg/day or 1,500 mg/day if higher dose not tolerated
Other Name: Niaspan
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
Other Name: Zocor
|
|
Active Comparator: Monotherapy
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
Other Name: Zocor
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00120289
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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 | |
| Cardiovascular Consultants Ltd | |
| Phoenix, Arizona, United States, 85015 | |
| Diabetes Center of Excellence | |
| Phoenix, Arizona, United States, 85016 | |
| 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 | |
| Berman Center for Outcomes and Clinical Research | |
| Minneapolis, Minnesota, United States, 55404 | |
| HealthPartners Riverside Clinic | |
| Minneapolis, Minnesota, United States, 55454 | |
| 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 | |
| VA New York Harbor Healthcare System | |
| New York, New York, United States, 10010 | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| 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 | |
| Pennsylvania Cardiology Associates | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Cardiology Consultants of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19148 | |
| 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 | |
| Kelsey Research Foundation | |
| Houston, Texas, United States, 77005 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| 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, Northwest Lipid Research Center | |
| Seattle, Washington, United States, 98104 | |
| University of Washington, Coronary Atherosclerosis Research Lab | |
| Seattle, Washington, United States, 98105 | |
| 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 | |
| Heart Health Institute | |
| Calgary, Alberta, Canada, T2E 7C5 | |
| Foothills Medical Centre | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| 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
National Heart, Lung, and Blood Institute (NHLBI)
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:
Study Data/Documents: Individual Participant Data Set
Identifier: AIM-HIGH
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
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 ( U.S. NIH Grant/Contract ) U01HL081616 ( U.S. NIH Grant/Contract ) |
| Study First Received: | July 6, 2005 |
| Results First Received: | June 1, 2015 |
| Last Updated: | March 8, 2016 |
Additional relevant MeSH terms:
|
Infarction Cardiovascular Diseases Heart Diseases Myocardial Infarction Atherosclerosis Coronary Disease Coronary Artery Disease Stroke Ischemia Pathologic Processes Necrosis Myocardial Ischemia Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Simvastatin Niacin Niacinamide Nicotinic Acids Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on July 21, 2017