Plaque Inflammation and Dysfunctional HDL in AIM-HIGH (HDL Proteomics)
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| ClinicalTrials.gov Identifier: NCT00880178 |
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Recruitment Status :
Completed
First Posted : April 13, 2009
Last Update Posted : May 14, 2018
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| Condition or disease | Intervention/treatment |
|---|---|
| Cardiovascular Diseases Heart Diseases Coronary Disease Atherosclerosis Myocardial Infarction | Drug: Simvastatin and Extended-Release niacin Drug: Simvastatin |
CHD is the leading cause of death in the United States. Preliminary research has shown that CHD is associated with oxidative and inflammatory changes in high-density lipoprotein (HDL) cholesterol, which is considered the "good" cholesterol. The inflammatory changes can impair HDL cholesterol's normal function, which is to remove excess cholesterol from the arteries and thereby slow the build-up of atherosclerotic plaque. Statins are cholesterol-lowering medications that are used to treat people with CHD. Taking niacin, a type of B vitamin, in combination with statins may stabilize atherosclerotic plaques better than statins alone, but more research is needed to examine how niacin may do this. By improving the ability of HDL cholesterol to repair inflammatory damage to atherosclerotic plaques, niacin may assist in preventing the inflammation that leads to plaque breakdown.
The AIM-HIGH study (NCT00120289) is examining the use of niacin plus statins in people with vascular disease. Participants in the AIM-HIGH study are randomly assigned to receive either niacin plus simvastatin, which is a type of statin medication, or simvastatin alone. The purpose of this substudy is to determine whether niacin in combination with statins reduces atherosclerotic plaque inflammation and dysfunctional HDL cholesterol more than statins alone. The substudy will enroll participants who are participating in the AIM-HIGH study. At the AIM-HIGH baseline and Year 2 study visits, study researchers for this substudy will collect an additional blood sample from participants to examine the changes in HDL oxidation levels and protein composition at both time points. Study researchers will also analyze participants' MRI scans to examine changes in plaque inflammation during the study period; these MRI scans will be completed as part of another AIM-HIGH substudy, conducted by Dr. Xue-Qiao Zhao. There will be no additional study procedures or visits for participants in this substudy.
| Study Type : | Observational |
| Actual Enrollment : | 324 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Plaque Inflammation and Dysfunctional HDL in AIM-HIGH |
| Study Start Date : | May 2008 |
| Actual Primary Completion Date : | August 2011 |
| Actual Study Completion Date : | September 2011 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Simvastatin
Participants in the main AIM-HIGH study who are receiving simvastatin.
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Drug: Simvastatin
Participants will be enrolled in this substudy only if they are candidates for the main AIM-HIGH study (NCT00120289). Participants will be randomly assigned to simvastatin or simvastatin plus niacin as a part of the main AIM-HIGH protocol, and adjustments in simvastatin and/or niacin doses will be made as per the protocol for the main AIM-HIGH study. |
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Simvastatin and Extended-Release Niacin
Participants in the main AIM-HIGH study who are receiving simvastatin and extended-release niacin.
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Drug: Simvastatin and Extended-Release niacin
Participants will be enrolled in this substudy only if they are candidates for the main AIM-HIGH study (NCT00120289). Participants will be randomly assigned to simvastatin or simvastatin plus niacin as a part of the main AIM-HIGH protocol, and adjustments in simvastatin and/or niacin doses will be made as per the protocol for the main AIM-HIGH study.
Other Name: Simvastatin/Niacin |
- Change in HDL oxidation and proteomics [ Time Frame: Measured at Year 2 ]
- Comparison of HDL oxidation and proteomics changes between participants receiving statins versus participants receiving statins plus niacin [ Time Frame: Measured at Year 2 ]
- Comparison of change in an MRI marker of plaque inflammation between participants receiving statins versus participants receiving statins plus niacin [ Time Frame: Measured at Year 2 ]
- Comparison of changes in HDL oxidation and proteomics with change in an MRI marker of plaque inflammation [ Time Frame: Measured at Year 2 ]
- Change in an MRI marker of plaque inflammation [ Time Frame: Measured at Year 2 ]
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Eligible for main AIM-HIGH study (NCT00120289)
- Willing to provide informed consent for participation in this substudy
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): NCT00880178
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| Principal Investigator: | Kevin D. O'Brien, MD | University of Washington |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kevin O'Brien, Professor of Medicine, Cardiology, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00880178 |
| Other Study ID Numbers: |
28201 R01HL089504 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 13, 2009 Key Record Dates |
| Last Update Posted: | May 14, 2018 |
| Last Verified: | February 2018 |
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Simvastatin Niacin Vascular Disease Magnetic Resonance Imaging High Density Lipoprotein |
Oxidation Proteomics Stroke Cerebrovascular Accident |
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Cardiovascular Diseases Myocardial Infarction Heart Diseases Atherosclerosis Coronary Disease Inflammation Infarction Pathologic Processes Ischemia Necrosis Myocardial Ischemia Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Niacin |
Niacinamide Nicotinic Acids Simvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Vasodilator Agents Vitamin B Complex Vitamins Micronutrients Physiological Effects of Drugs |