Participants in the main AIM-HIGH study who are receiving simvastatin.

Participants in the main AIM-HIGH study who are receiving simvastatin and extended-release niacin.

Coronary Artery Disease

Carotid Artery Diseases

Atherosclerosis

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.

Simvastatin, simvastatin plus extended-release niacin

Cardiovascular Consultants

Long Beach VA Medical Center

University of Southern California

University of Maryland

Johns Hopkins University

Mayo Clinic

Duke University

Wake Forest University

Philadelphia VA Medical Center

Baylor College of Medicine

Kelsey Research Foundation

Methodist Hospital

Harborview Medical Center

University of Washington

Puget Sound VA Medical Center, Seattle Campus

Heart Health Institute

University of Calgary

Vancouver General Hospital

University of Western Ontario

Carotid Plaque Characteristics by MRI in AIM-HIGH (Carotid MRI Substudy)

Carotid Plaque Characteristics by MRI in AIM-HIGH

To test the primary hypothesis that compared with LDL-lowering alone, intensive LDL-lowering plus HDL-raising therapy decreases the mean plaque lipid composition in carotid arteries assessed by MRI.

To test the additional hypotheses regarding plaque burden, plaque lipid depletion time course, association with cardiovascular event risk and lipid characteristics.

Xue-Qiao Zhao

Professor

National Heart, Lung, and Blood Institute (NHLBI)

Blood sample and scan results to be compared before and after intervention in each subject.

Blood sample and scan results to be compared before and after intervention in each subject.
Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.

Treatment Group (One Arm Only Study)

Sex: Female, Male

Region of Enrollment

Changes in FDG-PET/CT Dual Scan Score

Change in hs-CRP level before and after treatment in each subject

Changes in Hs-CRP Level

Change in IL-6 level before and after treatment in each subject

Changes in IL-6 Level

Albumin Level

Comparison of the average ESA dose used in the 3 month before and the last 3 months of the study.

ESA (Erythorpoietic Stimulating Agent) Dose Requirement

Hemoglobin Level

Comparison of the average major cardiovascular events (myocardial infarction and/or stroke) in the 3 month before and the last 3 months of the study.

Rate of Cardiovascular Events

Comparison of the average hemodialysis access stenosis/thrombosis requiring intervention in the 3 month before and the last 3 months of the study.

Hemodialysis Access Stenosis/Thrombosis

The number of subjects with significant rise in ALT but not to the extent requiring removal from the study (rise to more than 3 times the upper limit of the normal range)

Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase).

Overall Study

Kambiz Zandi-Nejad

Dialysis

Cardiovascular Disease

Inflammation

Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.

Extended Release Nicotinic Acid (Niaspan)

Brigham and Women's Hospital

BWH/FH/DCI Outpatient Dialysis Unit

DCI Dialysis Unit-Somerville

Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid

Kambiz Zandi-Nejad, MD

Instructor in Medicine

for 16 weeks :
week 1 = 375 mg per day,
week 2 = 500 mg per day,
week 3 = 750 mg per day,
week 4 = 1000 mg per day,
week 5 = 1500 mg per day,
weeks 6 to 16 = 2000 mg per day.

Obesity

the last 8 weeks, the subjects will follow a training program calculated to optimize use of lipid

training

Obese subjects will receive nicotinic acid or placebo for 16 weeks

nicotinic acid

Placebo

Centre d'Investigation Clinique, Purpan University Toulouse Hospital

Effect of Nicotinic Acid on Adipose Tissue Inflammation in Obese Subjects

University Hospital, Toulouse

Patients on Tredaptive are expected to have 15% increase in HDL cholesterol.

Hypercholesterolemia

Nicotinic acid/laropiprant (1g/20mg) daily for 4 weeks, then nicotinic acid/laropiprant (2g/40mg) daily for 8 weeks.

nicotinic acid/zápal

Carotid Plaque Characteristics by MRI in AIM-HIGH (Carotid MRI Substudy)

Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid

Effect of Nicotinic Acid on Adipose Tissue Inflammation in Obese Subjects

Effect of Tredaptive on Serum Lipoproteins and Inflammatory Markers

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