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Trial record 3 of 4 for:    aim-high

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:
ClinicalTrials.gov Identifier:
NCT00120289
First Posted: July 15, 2005
Last Update Posted: April 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Abbott
Information provided by (Responsible Party):
Ruth McBride, Axio Research. LLC
  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: Quadruple (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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


  Show 91 Study Locations
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  This link exits the ClinicalTrials.gov site
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.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: AIM-HIGH
Study forms  This link exits the ClinicalTrials.gov site
Identifier: AIM-HIGH

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 Submitted: July 6, 2005
First Posted: July 15, 2005
Results First Submitted: June 1, 2015
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