Niacin Plus Statin to Prevent Vascular Events

AIM HIGH: Niacin Plus Statin to Prevent Vascular Events

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.

Study Overview

• Status: Terminated
• Conditions: Myocardial Infarction; Heart Diseases; Cardiovascular Diseases; Coronary Disease; Atherosclerosis; Cerebrovascular Accident
• Intervention / Treatment: Drug: Extended release niacin; Drug: Simvastatin

Detailed Description

BACKGROUND:

Coronary heart disease (CHD) remains the leading cause of death and disability in the Western world, with approximately 12.6 million individuals in the United States having a history of myocardial infarction (MI), angina, or both. There is mounting evidence that "conventional" therapies aimed at traditional risk factors have not optimized clinical outcomes. For example, in the Heart Protection Study with 20,536 subjects, the 5-year risk of a first major vascular event (nonfatal MI or CHD death, stroke, or coronary or noncoronary revascularization) among placebo-treated patients was 25%. Treatment with simvastatin reduced this risk to 20% over 5 years, which would project out to a 10-year risk of 40%. (The National Cholesterol Education Program Adult Treatment Panel III considers "high risk" or CHD equivalent a 10-year risk of an event greater than 20%.) Even among patients entering the study with baseline low density lipoprotein cholesterol (LDL-C) already near or at goal (i.e., LDL-C less than 116 mg/dL) and who achieved a mean on-trial LDL-C of 70 mg/dL with simvastatin, the 5-year risk of an event was still 18% (projecting to a 10-year risk of 36%). This residual and unacceptably high risk is likely due to the increasing prevalence of obesity, type II diabetes mellitus, and the metabolic syndrome. These disorders are typically accompanied by a constellation of abnormalities that include impaired glycemic control, hypertension, procoagulant and inflammatory states, and atherogenic dyslipidemia. The latter includes a wide spectrum of lipid abnormalities (low HDL-C, high triglycerides and triglyceride-rich remnant lipoproteins, and a preponderance of small dense, highly-oxidizable LDL particles).

Conventional LDL-C-focused therapies are not effective in targeting this type of dyslipidemia. Evidence that therapy directed at atherogenic dyslipidemia among patients with CHD can lower outcomes was shown with gemfibrozil in the VA-HIT trial, which showed a 22 to 24% cardiovascular (CV) event reduction by raising HDL-C (by an average of 6%) and lowering triglycerides (by an average of 31%). Niacin is an even more effective agent for simultaneously raising HDL-C and lowering triglycerides and levels of small dense LDL, and holds the most promise among existing therapies for substantial risk reduction in this population when added to a statin. This was demonstrated in the HDL Atherosclerosis Treatment Study (HATS) trial in which atherosclerosis progression was virtually halted and CV events were reduced by 60 to 90% using combined niacin plus statin therapy.

DESIGN NARRATIVE:

AIM-HIGH is a multicenter, randomized, double-blind, parallel-group, controlled clinical trial designed to test whether the drug combination of extended release niacin plus simvastatin is superior to simvastatin alone, at comparable levels of on-treatment LDL-C, for delaying the time to a first major CV disease outcome over a 4-year median follow-up in patients with atherogenic dyslipidemia. Prior clinical trials have found only 25 to 35% CV risk reduction using statin monotherapy (i.e., event rate 2/3 to 3/4 of placebo rate). The study is needed to confirm whether statin-niacin combination therapy, designed to target a wider spectrum of dyslipidemic factors in addition to LDL-C, will provide a more substantial (greater than 50%) reduction of CV events. Epidemiologic studies confirm the high prevalence of atherogenic dyslipidemia and its impact on CV event rates. Preliminary clinical trials suggest that targeting these factors with dyslipidemic therapy will reduce CV events. The study will enroll an estimated 3,300 men and women more than 45 years old at high risk of recurrent CV events by virtue of having established CV disease together with the two dyslipidemic elements of metabolic syndrome: low HDL-cholesterol (HDL-C) (less than or equal to 40 mg/dl) and high triglycerides (TG) (greater than or equal to 150 mg/dl). The study specifically aims to test this hypothesis for the primary composite clinical end point of CHD death, nonfatal MI, ischemic stroke, hospitalization for acute coronary syndrome with objective evidence of ischemia (troponin-positive or ST-segment deviation), or symptom-driven coronary or cerebral revascularization. Secondary end points include the composite of CHD death, nonfatal MI, ischemic stroke, or hospitalization for high-risk acute coronary syndrome; the composite of CHD death, nonfatal MI or ischemic stroke; and cardiovascular mortality.

• Study Type: Interventional
• Enrollment (Actual): 3414
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: Zocor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 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

Outcome Measure	Time Frame
Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke	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 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 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.

Collaborators and Investigators

• Sponsor: Axio Research. LLC
• Collaborators: 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

Publications and helpful links

General Publications

• O'Brien KD, Hippe DS, Chen H, Neradilek MB, Probstfield JL, Peck S, Isquith DA, Canton G, Yuan C, Polissar NL, Zhao XQ, Kerwin WS. Longer duration of statin therapy is associated with decreased carotid plaque vascularity by magnetic resonance imaging. Atherosclerosis. 2016 Feb;245:74-81. doi: 10.1016/j.atherosclerosis.2015.11.032. Epub 2015 Dec 1.
• Ronsein GE, Vaisar T, Davidson WS, Bornfeldt KE, Probstfield JL, O'Brien KD, Zhao XQ, Heinecke JW. Niacin Increases Atherogenic Proteins in High-Density Lipoprotein of Statin-Treated Subjects. Arterioscler Thromb Vasc Biol. 2021 Aug;41(8):2330-2341. doi: 10.1161/ATVBAHA.121.316278. Epub 2021 Jun 17.
• AIM-HIGH Investigators. The role of niacin in raising high-density lipoprotein cholesterol to reduce cardiovascular events in patients with atherosclerotic cardiovascular disease and optimally treated low-density lipoprotein cholesterol: baseline characteristics of study participants. The Atherothrombosis Intervention in Metabolic syndrome with low HDL/high triglycerides: impact on Global Health outcomes (AIM-HIGH) trial. Am Heart J. 2011 Mar;161(3):538-43. doi: 10.1016/j.ahj.2010.12.007. Epub 2011 Feb 2.
• AIM-HIGH Investigators. The role of niacin in raising high-density lipoprotein cholesterol to reduce cardiovascular events in patients with atherosclerotic cardiovascular disease and optimally treated low-density lipoprotein cholesterol Rationale and study design. The Atherothrombosis Intervention in Metabolic syndrome with low HDL/high triglycerides: Impact on Global Health outcomes (AIM-HIGH). Am Heart J. 2011 Mar;161(3):471-477.e2. doi: 10.1016/j.ahj.2010.11.017. Epub 2011 Feb 2.
• AIM-HIGH Investigators; Boden WE, Probstfield JL, Anderson T, Chaitman BR, Desvignes-Nickens P, Koprowicz K, McBride R, Teo K, Weintraub W. Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. N Engl J Med. 2011 Dec 15;365(24):2255-67. doi: 10.1056/NEJMoa1107579. Epub 2011 Nov 15. Erratum In: N Engl J Med. 2012 Jul 12;367(2):189.
• Teo KK, Goldstein LB, Chaitman BR, Grant S, Weintraub WS, Anderson DC, Sila CA, Cruz-Flores S, Padley RJ, Kostuk WJ, Boden WE; AIM-HIGH Investigators. Extended-release niacin therapy and risk of ischemic stroke in patients with cardiovascular disease: the Atherothrombosis Intervention in Metabolic Syndrome with low HDL/High Triglycerides: Impact on Global Health Outcome (AIM-HIGH) trial. Stroke. 2013 Oct;44(10):2688-93. doi: 10.1161/STROKEAHA.113.001529. Epub 2013 Jul 23.
• Albers JJ, Slee A, O'Brien KD, Robinson JG, Kashyap ML, Kwiterovich PO Jr, Xu P, Marcovina SM. Relationship of apolipoproteins A-1 and B, and lipoprotein(a) to cardiovascular outcomes: the AIM-HIGH trial (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglyceride and Impact on Global Health Outcomes). J Am Coll Cardiol. 2013 Oct 22;62(17):1575-9. doi: 10.1016/j.jacc.2013.06.051. Epub 2013 Aug 21.
• Guyton JR, Slee AE, Anderson T, Fleg JL, Goldberg RB, Kashyap ML, Marcovina SM, Nash SD, O'Brien KD, Weintraub WS, Xu P, Zhao XQ, Boden WE. Relationship of lipoproteins to cardiovascular events: the AIM-HIGH Trial (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides and Impact on Global Health Outcomes). J Am Coll Cardiol. 2013 Oct 22;62(17):1580-4. doi: 10.1016/j.jacc.2013.07.023. Epub 2013 Jul 31.
• Tuteja S, Qu L, Vujkovic M, Dunbar RL, Chen J, DerOhannessian S, Rader DJ. Genetic Variants Associated With Plasma Lipids Are Associated With the Lipid Response to Niacin. J Am Heart Assoc. 2018 Oct 2;7(19):e03488. doi: 10.1161/JAHA.117.008461.
• Toth PP, Jones SR, Slee A, Fleg J, Marcovina SM, Lacy M, McBride R, Boden WE. Relationship between lipoprotein subfraction cholesterol and residual risk for cardiovascular outcomes: A post hoc analysis of the AIM-HIGH trial. J Clin Lipidol. 2018 May-Jun;12(3):741-747.e11. doi: 10.1016/j.jacl.2018.03.077. Epub 2018 Mar 9.

Helpful Links

• AIM-HIGH Web site for patients

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 6, 2005
• First Submitted That Met QC Criteria: July 6, 2005
• First Posted (Estimate): July 15, 2005

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: March 8, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Heart Diseases; Stroke; Coronary Disease; Cardiovascular Diseases; Atherosclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Micronutrients; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Vitamins; Vitamin B Complex; Simvastatin; Niacin
• Other Study ID Numbers: 226; U01HL081649 (U.S. NIH Grant/Contract); U01HL081616 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: AIM-HIGH
   Information comments: 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.
2. Study Protocol
   Information identifier: AIM-HIGH
3. Study forms
   Information identifier: AIM-HIGH