Niacin Plus Statin to Prevent Vascular Events
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00120289
First received: July 6, 2005
Last updated: June 3, 2011
Last verified: June 2011
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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 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
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
|
Show Detailed Description 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
Show 91 Study Locations
Show 91 Study LocationsSponsors and Collaborators
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:
No publications provided by National Heart, Lung, and Blood Institute (NHLBI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 June 13, 2013