Niacin Plus Statin to Prevent Vascular Events
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ClinicalTrials.gov Identifier: NCT00120289 |
Recruitment Status
:
Terminated
(AIM-HIGH was stopped on the recommendation of the DSMB because of lack of efficacy of niacin in preventing primary outcome events.)
First Posted
: July 15, 2005
Results First Posted
: June 17, 2015
Last Update Posted
: April 6, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Diseases Heart Diseases Cerebrovascular Accident Coronary Disease Atherosclerosis Myocardial Infarction | Drug: Extended release niacin Drug: Simvastatin | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3414 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | AIM HIGH: Niacin Plus Statin to Prevent Vascular Events |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | December 2012 |
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 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
|
- 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. ]
- 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. ]

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Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120289

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 |
Additional Information:
Study Data/Documents: Individual Participant Data Set

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 of Results:
Other Publications:
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 ) |
First Posted: | July 15, 2005 Key Record Dates |
Results First Posted: | June 17, 2015 |
Last Update Posted: | April 6, 2016 |
Last Verified: | March 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 |