Carotid Artery Disease, Coronary Artery Disease, Peripheral Artery Disease
Conditions
Brief summary
This study is looking to see if niacin will lessen atherosclerotic plaque inflammation and favorably affect circulating levels of endothelial progenitor cells and microparticles in people with atherosclerotic disease on chronic statin therapy.
Interventions
DRUGNiacin
Niacin titrated to 6000 mg daily
DRUGPlacebo
Placebo provided in the same pill quantity as niacin arm
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men age 55 years and above with coronary artery disease or women age 65 years and above with coronary artery disease OR Men age 45 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease or women age 55 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease. * Subjects must be on statin monotherapy, defined as a stable statin dose for at least 12 weeks, with no anticipated need for further titration during the study period
Exclusion criteria
* Anxiety or claustrophobia prohibiting imaging * History of allergy to intravenous contrast, iodine, or shellfish * Renal insufficiency * History of allergy or severe intolerance to niacin * History of diabetes mellitus or elevated fasting glucose * Moderate to severe gout * Peptic ulcer disease * Acute coronary syndrome, transient ischemic attack or cerebrovascular accident, or acute limb ischemia in the preceding 12 months * Heart failure or unstable angina pectoris * Use of daily non-statin lipid-altering therapy prior to the initiation of study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT | 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Niacin Niacin titrated up to 6 grams taken orally every day for 12 weeks | 5 |
| Placebo Placebo taken orally every day for 12 weeks | 3 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Niacin |
|---|---|---|---|
| Age, Continuous | 66 years | 64 years | 63 years |
| Body-mass index | 32 kg/m^2 | 30.0 kg/m^2 | 28.9 kg/m^2 |
| Coronary artery disease | 3 participants | 8 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 5 | 0 / 3 |
| serious Total, serious adverse events | 1 / 5 | 0 / 3 |
Outcome results
Primary
Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Niacin | Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT | -0.02 Target to Background Ratio (TBR) | Standard Deviation 0.14 |
| Placebo | Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT | -0.05 Target to Background Ratio (TBR) | Standard Deviation 0.12 |