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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:
Axio Research. LLC
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Abbott
Information provided by (Responsible Party):
Ruth McBride, Axio Research. LLC
ClinicalTrials.gov Identifier:
NCT00120289
First received: July 6, 2005
Last updated: March 8, 2016
Last verified: March 2016
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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| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120289
Show 91 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
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.
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 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 ) |
| Study First Received: | July 6, 2005 |
| Results First Received: | June 1, 2015 |
| Last Updated: | March 8, 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 |
ClinicalTrials.gov processed this record on August 21, 2017