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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niacin | Experimental | Niacin titrated up to 6 grams taken orally every day for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo taken orally every day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niacin | Drug | Niacin titrated to 6000 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emil deGoma, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Niacin | Niacin titrated up to 6 grams taken orally every day for 12 weeks |
| FG001 | Placebo | Placebo taken orally every day for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Niacin | Niacin titrated up to 6 grams taken orally every day for 12 weeks |
| BG001 | Placebo | Placebo taken orally every day for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT | Posted | Mean | Standard Deviation | Target to Background Ratio (TBR) | 12 weeks |
|
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Niacin | Niacin titrated up to 6 grams taken orally every day for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Non-systematic Assessment | At week 11, hospitalized for abdominal discomfort, nausea, chest pain. Vital signs, serial ECG, cardiac enzymes, chest radiography, and hemoglobin were normal. His symptoms resolved spontaneously within 24 hours without cessation of study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rocky Mountain Spotted Fever | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emil deGoma | University of Pennsylvania | 2156156521 | emil.degoma@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002340 | Carotid Artery Diseases |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Placebo | Drug | Placebo provided in the same pill quantity as niacin arm |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body-mass index | Mean | Full Range | kg/m^2 |
|
| Coronary artery disease | Number | participants |
|
|
| 1 |
| 5 |
| 3 |
| 5 |
| EG001 | Placebo | Placebo taken orally every day for 12 weeks | 0 | 3 | 0 | 3 |
|
| Bacterial pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Chronic pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Asymptomatic. Incidental finding of chronic pulmonary emboli on baseline CT |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D050197 | Atherosclerosis |
| D016491 | Peripheral Vascular Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D002241 | Carbohydrates |