AzTrials
AzTrials

Cardiovascular DiseasesPhase 3NCT00120289

Niacin Plus Statin to Prevent Vascular Events

A Phase 3 study testing Extended release niacin and Simvastatin in people with Cardiovascular Diseases and Heart Diseases, run by Axio Research. LLC at 91 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
What is being tested?
Extended release niacin and Simvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,414 participants
Where
91 sitesin 2 countries
Study dates
Sep 2005to Dec 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

91 sites in 2 countries.

91 sites in 2 countries

United States68 sites

  • New Mexico VA Healthcare Systems

    Albuquerque, New Mexico, 87108

  • Veterans Affairs Health System of Ann Arbor, Michigan

    Ann Arbor, Michigan, 48105

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Cardiovascular Associates, P.C.

    Birmingham, Alabama, 35213

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35294

  • Grunberger Diabetes Institute

    Bloomfield Hills, Michigan, 48302

  • Kaleida Health/Diabetes Center

    Buffalo, New York, 14209

  • Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • University of Virginia - UVA Cardiology

    Charlottesville, Virginia, 22908

  • Cooper Clinical Trials Center

    Cherry Hill, New Jersey, 08034

  • Sterling Research Group, Ltd.

    Cincinnati, Ohio, 45219

  • St Vincent Charity Hospital - The Center for Vascular Health

    Cleveland, Ohio, 44115

  • Iowa Heart Center, P.C.

    Des Moines, Iowa, 50314

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Cardiovascular Associates of the Delaware Valley

    Elmer, New Jersey, 08318

  • Parkview Research Center

    Fort Wayne, Indiana, 46805

  • Wake Forest University - Geriatrics/Gerontology

    Greensboro, North Carolina, 27157

  • Internal Medicine Associates of Greenville

    Greenville, South Carolina, 29607

  • Pentucket Medical Associates

    Haverhill, Massachusetts, 01830

  • Clinical Research Consultants, Inc.

    Hoover, Alabama, 35216

  • Kelsey Research Foundation

    Houston, Texas, 77005

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Methodist Hospital

    Houston, Texas, 77030

  • Lipid Research Clinic, University of Iowa

    Iowa City, Iowa, 52240

  • G.V. (Sonny) Montgomery VAMC

    Jackson, Mississippi, 39216

  • Mid Valley Cardiology

    Kingston, New York, 12401

  • University of Arkansas

    Little Rock, Arkansas, 72205

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • VAMC Memphis - Hypertension/Lipid Research Clinic

    Memphis, Tennessee, 38104

  • University of Miami

    Miami, Florida, 33136

  • Berman Center for Outcomes and Clinical Research

    Minneapolis, Minnesota, 55404

  • HealthPartners Riverside Clinic

    Minneapolis, Minnesota, 55454

  • Providence Holy Cross Medical Center

    Mission Hills, California, 91345

  • Intermountain Medical Center

    Murray, Utah, 84157

  • UMDNJ -Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • VA New York Harbor Healthcare System

    New York, New York, 10010

  • Columbia University

    New York, New York, 10032

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • Alegent Health Heart & Vascular Specialists

    Papillion, Nebraska, 68046

  • Carl T. Hayden VAMC Phoenix Medical Service

    Pheonix, Arizona, 85012

  • Philadelphia VA Medical Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Cardiology Associates

    Philadelphia, Pennsylvania, 19106

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania, 19148

  • Cardiovascular Consultants Ltd

    Phoenix, Arizona, 85015

  • Diabetes Center of Excellence

    Phoenix, Arizona, 85016

  • Idaho State University

    Pocatello, Idaho, 83201

  • Portland VA Medical Center

    Portland, Oregon, 97239

  • Women's Cardiac Center at The Miriam Hospital

    Providence, Rhode Island, 02906

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Phalen Village Clinic

    Saint Paul, Minnesota, 55106

  • North Ohio Research, Ltd.

    Sandusky, Ohio, 44870

  • Heart & Vascular Research Center

    Sarasota, Florida, 34239

  • Maine Center for Lipids & Cardiovascular Health

    Scarborough, Maine, 04074

  • University of Washington, Northwest Lipid Research Center

    Seattle, Washington, 98104

  • University of Washington, Coronary Atherosclerosis Research Lab

    Seattle, Washington, 98105

  • VA Cardiology Research

    Seattle, Washington, 98108

  • Washington State University

    Spokane, Washington, 99202

  • St. Louis University

    St Louis, Missouri, 63104

  • Syracuse Preventive Cardiology

    Syracuse, New York, 13202

  • James A. Haley Veteran's Hospital

    Tampa, Florida, 33612

  • Tucson Clinical Research (Eastside Site)

    Tucson, Arizona, 85712

  • Tucson Clinical Research (Northwest Site)

    Tucson, Arizona, 85741

  • University of Minnesota

    Twin Cities, Minnesota, 55414

  • CARE Foundation, Inc.

    Wausau, Wisconsin, 54401

  • Wake Forest University Health Sciences - Department of Cardiology

    Winston-Salem, North Carolina, 27157

  • Wake Forest University School of Medicine - Internal Medicine/Endocrinology

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada23 sites

  • Heart Health Institute

    Calgary, Alberta, T2E 7C5

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • Cambridge Cardiac Care Center

    Cambridge, Ontario, N1R 6V6

  • McConnell Medical Center

    Cornwall, Ontario, K6H 4M4

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • Sudbury Cardiovascular Research

    Greater Sudbury, Ontario, P3E 2N8

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia, B3H 3A6

  • Hamilton Health Sciences - General Site

    Hamilton, Ontario, L8L 2X2

  • Cardiology Associates VRH

    Kentville, Nova Scotia, B4N 5E3

  • Clinique de Cardiologie de Lévis

    Lévis, Quebec, G6V 4Z5

  • LHSC University Hospital

    London, Ontario, N6A 5A5

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Newmarket Cardiology Research Group

    Newmarket, Ontario, L3Y 8C3

  • Recherches Clinicar

    Québec, Quebec, G1J 1Z6

  • Clinique des maladies lipidiques de Québec

    Québec, Quebec, G1V 4M6

  • New Brunswick Heart Center

    Saint John, New Brunswick, E2L 4L2

  • CSSS Beauce

    St-Georges de Beauce, Quebec, G5Y 4T8

  • Memorial University of Newfoundland

    St. John's, Newfoundland and Labrador, A1B 3V6

  • CSSS du Sud de Lanaudière - Hôpital Pierre-Le Gardeur

    Terrebonne, Quebec, J6V 2H2

  • St. Michael's Hospital Health Centre

    Toronto, Ontario, M5C 2T2

  • Vancouver Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Victoria Heart Institute

    Victoria, British Columbia, V8R 4R2

  • Health Sciences Center, Diabetes Research Group

    Winnipeg, Manitoba, R3E 3R4

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Extended release niacin, Simvastatin
Medical subject headings
Cardiovascular Diseases, Heart Diseases, Stroke, Coronary Disease, Atherosclerosis, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extended release niacinDrug

    Also called Niaspan

    2,000 mg/day or 1,500 mg/day if higher dose not tolerated

  • SimvastatinDrug

    Also called Zocor

    Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target

Study groups in NCT00120289
Study groupRoleWhat they receive
Combination TherapyExperimentalExtended release niacin plus simvastatin
Receives: Drug: Extended release niacin; Drug: Simvastatin
MonotherapyActive comparatorSimvastatin alone
Receives: Drug: Simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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 outcomes (3)

  1. Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke

    Measured: 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

  2. Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke

    Measured: 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

  3. Cardiovascular Mortality

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionSep 2012
  4. Study completionDec 2012

Why it stopped: AIM-HIGH was stopped on the recommendation of the DSMB because of lack of efficacy of niacin in preventing primary outcome events.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00120289
Sponsor's protocol ID
226
Other IDs
U01HL081649, U01HL081616
Status last verified
Mar 2016
First submitted
6 Jul 2005
Last updated
6 Apr 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21392609

  • 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.

    PubMed 21392600

  • 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.

    PubMed 22085343

  • 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.

    PubMed 23881958

  • 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.

    PubMed 23973688

  • 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.

    PubMed 23916935

  • 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.

    PubMed 34134520

  • 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.

    PubMed 30371334

  • 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.

    PubMed 29627296

  • 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.

    PubMed 26708287

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Extended release niacin and Simvastatin in people with Cardiovascular Diseases and Heart Diseases, run by Axio Research. LLC at 91 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00120289, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.

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