Niacin Plus Statin to Prevent Vascular Events - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Collaborator:	Abbott
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00120289

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:

MedlinePlus related topics: Atherosclerosis Coronary Artery Disease Heart Attack Heart Diseases Statins

Drug Information available for: Niacin Niacinamide Simvastatin

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Composite end point of CHD death, nonfatal MI, ischemic stroke, hospitalization for non-ST segment elevation acute coronary syndrome, 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
Estimated Study Completion Date:	September 2012
Estimated 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

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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

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

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Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Abbott

Investigators

Study Director:	Ruth McBride	Axio Research Corporation
Principal Investigator:	William E. Boden, MD	SUNY-Buffalo
Principal Investigator:	Jeffrey Probstfield, MD	University of Washington

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

NHLBI Press Release on Stopping AIM-HIGH This link exits the ClinicalTrials.gov site

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Nov 15.

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. 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. Epub 2011 Feb 2.

Responsible Party:	Jeffrey L. Probstfield, MD and William E. Boden, MD, University of Washington and SUNY Buffalo
ClinicalTrials.gov Identifier:	NCT00120289 History of Changes
Other Study ID Numbers:	226, U01 HL81616, U01 HL81649
Study First Received:	July 6, 2005
Last Updated:	June 3, 2011
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Atherosclerosis
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Heart Diseases
Infarction
Myocardial Infarction
Cerebral Infarction
Stroke
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Myocardial Ischemia
Ischemia
Pathologic Processes

Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Niacin
Simvastatin
Nicotinic Acids
Niacinamide
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2012