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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL063895-05A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Pfizer | INDUSTRY |
| Abbott | INDUSTRY |
| Daiichi Sankyo |
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Atherosclerosis is a condition that occurs when fatty deposits build up along the inner walls of arteries. This study will examine the effectiveness of a combination of cholesterol-lowering medications at decreasing the fat content of atherosclerotic deposits in people who have coronary artery disease or carotid artery disease.
Atherosclerosis is a condition in which deposits of fat, cholesterol, and other substances build up along the inner walls of arteries; these deposits are known as plaque. People with atherosclerosis are at risk of developing coronary artery disease, in which plaque build-up occurs in the arteries that supply blood to the heart, and carotid artery disease, in which plaque build-up occurs in the arteries that deliver blood through the neck to the brain. These conditions can lead to blood clots, heart attack, and stroke. Research has shown that people who have more fat content in atherosclerotic plaque may have a higher risk of experiencing a heart attack or stroke. Treatments for atherosclerosis include lifestyle changes, medicines, and medical procedures or surgery. There are several medications that can aid people in controlling their cholesterol levels, including atorvastatin, a medication that inhibits the production of cholesterol; niacin, a B-complex vitamin that can reduce cholesterol levels in combination with dietary changes; and colesevelam, a medication that inhibits fat absorption. Using magnetic resonance imaging (MRI), this study will evaluate whether these medications, alone or in combination, can decrease the fat content of atherosclerotic plaques within the carotid arteries of people with coronary artery disease and carotid artery disease.
This study will enroll people with coronary artery disease or carotid artery disease. Participants will be randomly assigned to one of the following 40-month treatment groups:
At a baseline study visit, participants will undergo a blood collection and will receive dietary counseling that will focus on lowering cholesterol levels. They will also undergo an MRI scan of their carotid arteries. For the next 4 months, participants will attend monthly study visits for repeat blood collection and dietary counseling; for the subsequent 36 months, participants will attend study visits every other month. Repeat carotid artery MRI scans will occur at Months 12, 24, and 36. At three different times during the study, researchers will ask participants to record their food consumption for 3 consecutive days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - single therapy group | Active Comparator | Participants will receive atorvastatin, placebo niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the single therapy group. |
|
| 2 - double therapy group | Experimental | Participants will receive atorvastatin, niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the double therapy group. |
|
| 3 - triple therapy group | Experimental | Participants will receive atorvastatin, niacin, and colesevelam. The treatment target for LDL-C will be ≤60 mg/dl for the triple therapy group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 10 to 80 mg of atorvastatin each day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized LRNC Volume Change in Carotid Plaque Composition, as Assessed by MRI | The primary endpoint of this study is carotid plaque lipid composition identified by MRI. The determination of plaque lipid content for each carotid artery will be performed using the automated interactive system. These measurements will be performed from the MRI scans at four time points blinded to time sequence of MRI examinations, patient treatment, lipid levels and clinical course. Volume Measurements: Contours were placed around the lumen, outer-wall boundaries, and plaque features of carotid artery. (Arterial wall area) = (outer-wall area) - (lumen area). Volume calculated as: area x 2 mm (slice thickness). Tissue volume/wall volume x (100%) is presented as percentage. Annualized change presented mm^3/year (for volume) and as percentage change/year. | Measured at Years 1, 2, and 3 |
| Annualized LRNC and Wall Volume Changes in Carotid Plaque Composition, as Assessed by MRI | The primary endpoint of this study is carotid plaque lipid composition identified by MRI. The determination of plaque lipid content for each carotid artery will be performed using the automated interactive system. These measurements will be performed from the MRI scans at four time points blinded to time sequence of MRI examinations, patient treatment, lipid levels and clinical course. Volume Measurements: Contours were placed around the lumen, outer-wall boundaries, and plaque features of carotid artery. (Arterial wall area) = (outer-wall area) - (lumen area). Volume calculated as: area x 2 mm (slice thickness). Tissue volume/wall volume x (100%) is presented as percentage. Annualized change presented mm^3/year (for volume) and as percentage change/year. | Measured at Years 1, 2, and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Cardiovascular Endpoints: Number of Participants With Cardiovascular Disease Death, Non-fatal Heart Attack, Stroke, and Worsening Ischemia Requiring Medical Interventions | Any cardiovascular events such as death from any cause, nonfatal myocardial infarction, stroke, and revascularization procedures (PCI or CABG) due to unstable ischemia will be recorded and verified. | Measured at Years 3, 4, and 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xue-Qiao Zhao, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | United States | ||
| St. Luke's Idaho Cardiology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17643572 | Result | Zhao XQ, Phan BA, Chu B, Bray F, Moore AB, Polissar NL, Dodge JT Jr, Lee CD, Hatsukami TS, Yuan C. Testing the hypothesis of atherosclerotic plaque lipid depletion during lipid therapy by magnetic resonance imaging: study design of Carotid Plaque Composition Study. Am Heart J. 2007 Aug;154(2):239-46. doi: 10.1016/j.ahj.2007.04.035. | |
| 21291704 | Result | Moore A, Phan BA, Challender C, Williamson J, Marcovina S, Zhao XQ. Effects of adding extended-release niacin and colesevelam to statin therapy on lipid levels in subjects with atherosclerotic disease. J Clin Lipidol. 2007 Dec;1(6):620-5. doi: 10.1016/j.jacl.2007.09.001. Epub 2007 Sep 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 - Single Therapy Group | Participants will receive atorvastatin, placebo niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the single therapy group. Atorvastatin: 10 to 80 mg of atorvastatin each day Placebo Niacin: Placebo niacin each day Placebo Colesevelam: Placebo colesevelam each day |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2016 |
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| INDUSTRY |
| Upsher-Smith Laboratories | INDUSTRY |
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| Niacin | Drug | 2000 mg of niacin each day |
|
|
| Colesevelam | Drug | 3.8 g of colesevelam each day |
|
|
| Placebo Niacin | Drug | Placebo niacin each day |
|
| Placebo Colesevelam | Drug | Placebo colesevelam each day |
|
| Boise |
| Idaho |
| 83712 |
| United States |
| University of Washington Coronary Atherosclerosis Research Lab | Seattle | Washington | 98104 | United States |
| Yakima Heart Center | Yakima | Washington | 98902 | United States |
| 18765395 | Result | Green PS, Vaisar T, Pennathur S, Kulstad JJ, Moore AB, Marcovina S, Brunzell J, Knopp RH, Zhao XQ, Heinecke JW. Combined statin and niacin therapy remodels the high-density lipoprotein proteome. Circulation. 2008 Sep 16;118(12):1259-67. doi: 10.1161/CIRCULATIONAHA.108.770669. Epub 2008 Sep 2. |
| 23168285 | Result | Phan BA, Munoz L, Shadzi P, Isquith D, Triller M, Brown BG, Zhao XQ. Effects of niacin on glucose levels, coronary stenosis progression, and clinical events in subjects with normal baseline glucose levels (<100 mg/dl): a combined analysis of the Familial Atherosclerosis Treatment Study (FATS), HDL-Atherosclerosis Treatment Study (HATS), Armed Forces Regression Study (AFREGS), and Carotid Plaque Composition by MRI during lipid-lowering (CPC) study. Am J Cardiol. 2013 Feb 1;111(3):352-5. doi: 10.1016/j.amjcard.2012.09.034. Epub 2012 Nov 17. |
| 26681752 | Result | Ronsein GE, Hutchins PM, Isquith D, Vaisar T, Zhao XQ, Heinecke JW. Niacin Therapy Increases High-Density Lipoprotein Particles and Total Cholesterol Efflux Capacity But Not ABCA1-Specific Cholesterol Efflux in Statin-Treated Subjects. Arterioscler Thromb Vasc Biol. 2016 Feb;36(2):404-11. doi: 10.1161/ATVBAHA.115.306268. Epub 2015 Dec 17. |
| 27737745 | Result | Zhao XQ, Yuan C, Shah PK. Imaging to Assess the Effect of Anti-Inflammatory Therapy in Aortic and Carotid Atherosclerosis. J Am Coll Cardiol. 2016 Oct 18;68(16):1781-1784. doi: 10.1016/j.jacc.2016.08.011. No abstract available. |
| 34401861 | Result | Chu MP, Many G, Isquith DA, McKeeth S, Williamson J, Neradilek MB, Colletti P, Zhao XQ. Metabolic and inflammatory risk reduction in response to lipid-lowering and lifestyle modification in the medically underserved individuals. Am J Prev Cardiol. 2021 Jul 31;7:100227. doi: 10.1016/j.ajpc.2021.100227. eCollection 2021 Sep. |
| 32020410 | Result | Han T, Paramsothy P, Hong J, Isquith D, Xu D, Bai H, Neradilek M, Gill E, Zhao XQ. High-resolution MRI assessed carotid atherosclerotic plaque characteristics comparing men and women with elevated ApoB levels. Int J Cardiovasc Imaging. 2020 Mar;36(3):481-489. doi: 10.1007/s10554-019-01600-1. Epub 2020 Feb 4. |
| 21920335 | Result | Zhao XQ, Dong L, Hatsukami T, Phan BA, Chu B, Moore A, Lane T, Neradilek MB, Polissar N, Monick D, Lee C, Underhill H, Yuan C. MR imaging of carotid plaque composition during lipid-lowering therapy a prospective assessment of effect and time course. JACC Cardiovasc Imaging. 2011 Sep;4(9):977-86. doi: 10.1016/j.jcmg.2011.06.013. |
| 21493792 | Result | Dong L, Kerwin WS, Chen H, Chu B, Underhill HR, Neradilek MB, Hatsukami TS, Yuan C, Zhao XQ. Carotid artery atherosclerosis: effect of intensive lipid therapy on the vasa vasorum--evaluation by using dynamic contrast-enhanced MR imaging. Radiology. 2011 Jul;260(1):224-31. doi: 10.1148/radiol.11101264. Epub 2011 Apr 14. |
| 19557844 | Result | Kerwin WS, Zhao X, Yuan C, Hatsukami TS, Maravilla KR, Underhill HR, Zhao X. Contrast-enhanced MRI of carotid atherosclerosis: dependence on contrast agent. J Magn Reson Imaging. 2009 Jul;30(1):35-40. doi: 10.1002/jmri.21826. |
| 34134520 | Derived | Ronsein GE, Vaisar T, Davidson WS, Bornfeldt KE, Probstfield JL, O'Brien KD, Zhao XQ, Heinecke JW. Niacin Increases Atherogenic Proteins in High-Density Lipoprotein of Statin-Treated Subjects. Arterioscler Thromb Vasc Biol. 2021 Aug;41(8):2330-2341. doi: 10.1161/ATVBAHA.121.316278. Epub 2021 Jun 17. |
| 2 - Double Therapy Group |
Participants will receive atorvastatin, niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the double therapy group. Atorvastatin: 10 to 80 mg of atorvastatin each day Niacin: 2000 mg of niacin each day Placebo Colesevelam: Placebo colesevelam each day |
| FG002 | 3 - Triple Therapy Group | Participants will receive atorvastatin, niacin, and colesevelam. The treatment target for LDL-C will be ≤60 mg/dl for the triple therapy group Atorvastatin: 10 to 80 mg of atorvastatin each day Niacin: 2000 mg of niacin each day Colesevelam: 3.8 g of colesevelam each day |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1 - Single Therapy Group | Participants will receive atorvastatin, placebo niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the single therapy group. Atorvastatin: 10 to 80 mg of atorvastatin each day Placebo Niacin: Placebo niacin each day Placebo Colesevelam: Placebo colesevelam each day |
| BG001 | 2 - Double Therapy Group | Participants will receive atorvastatin, niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the double therapy group. Atorvastatin: 10 to 80 mg of atorvastatin each day Niacin: 2000 mg of niacin each day Placebo Colesevelam: Placebo colesevelam each day |
| BG002 | 3 - Triple Therapy Group | Participants will receive atorvastatin, niacin, and colesevelam. The treatment target for LDL-C will be ≤60 mg/dl for the triple therapy group Atorvastatin: 10 to 80 mg of atorvastatin each day Niacin: 2000 mg of niacin each day Colesevelam: 3.8 g of colesevelam each day |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Family history of premature cardiovascular disease, n (%) | Count of Participants | Participants |
| ||||||||||||||||
| History of myocardial infarction, n (%) | Count of Participants | Participants |
| ||||||||||||||||
| Established coronary artery disease, n (%) | Count of Participants | Participants |
| ||||||||||||||||
| Hypertension, n (%) | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes, n (%) | Count of Participants | Participants |
| ||||||||||||||||
| Current smoking, n (%) | Count of Participants | Participants |
|
| 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 | Annualized LRNC Volume Change in Carotid Plaque Composition, as Assessed by MRI | The primary endpoint of this study is carotid plaque lipid composition identified by MRI. The determination of plaque lipid content for each carotid artery will be performed using the automated interactive system. These measurements will be performed from the MRI scans at four time points blinded to time sequence of MRI examinations, patient treatment, lipid levels and clinical course. Volume Measurements: Contours were placed around the lumen, outer-wall boundaries, and plaque features of carotid artery. (Arterial wall area) = (outer-wall area) - (lumen area). Volume calculated as: area x 2 mm (slice thickness). Tissue volume/wall volume x (100%) is presented as percentage. Annualized change presented mm^3/year (for volume) and as percentage change/year. | Analysis group was limited from total study population due to the need for detectable lipid-rich necrotic core (LRNC) measurement at study baseline. | Posted | Mean | Standard Error | mm^3/year | Measured at Years 1, 2, and 3 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Composite of Cardiovascular Endpoints: Number of Participants With Cardiovascular Disease Death, Non-fatal Heart Attack, Stroke, and Worsening Ischemia Requiring Medical Interventions | Any cardiovascular events such as death from any cause, nonfatal myocardial infarction, stroke, and revascularization procedures (PCI or CABG) due to unstable ischemia will be recorded and verified. | Posted | Count of Participants | Participants | Measured at Years 3, 4, and 5 |
| |||||||||||||||||||||||||||||||||||
| Primary | Annualized LRNC and Wall Volume Changes in Carotid Plaque Composition, as Assessed by MRI | The primary endpoint of this study is carotid plaque lipid composition identified by MRI. The determination of plaque lipid content for each carotid artery will be performed using the automated interactive system. These measurements will be performed from the MRI scans at four time points blinded to time sequence of MRI examinations, patient treatment, lipid levels and clinical course. Volume Measurements: Contours were placed around the lumen, outer-wall boundaries, and plaque features of carotid artery. (Arterial wall area) = (outer-wall area) - (lumen area). Volume calculated as: area x 2 mm (slice thickness). Tissue volume/wall volume x (100%) is presented as percentage. Annualized change presented mm^3/year (for volume) and as percentage change/year. | Analysis group was limited from total study population due to the need for detectable lipid-rich necrotic core (LRNC) measurement at study baseline. | Posted | Mean | Standard Error | percentage change/year | Measured at Years 1, 2, and 3 |
|
Period of time from study baseline visit until subject completion. Subject followed for up to 168 months in open label follow-up period.
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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 | 1 - Single Therapy Group | Participants will receive atorvastatin, placebo niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the single therapy group. Atorvastatin: 10 to 80 mg of atorvastatin each day Placebo Niacin: Placebo niacin each day Placebo Colesevelam: Placebo colesevelam each day | 7 | 71 | 26 | 71 | 34 | 71 |
| EG001 | 2 - Double Therapy Group | Participants will receive atorvastatin, niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the double therapy group. Atorvastatin: 10 to 80 mg of atorvastatin each day Niacin: 2000 mg of niacin each day Placebo Colesevelam: Placebo colesevelam each day | 7 | 73 | 20 | 73 | 40 | 73 |
| EG002 | 3 - Triple Therapy Group | Participants will receive atorvastatin, niacin, and colesevelam. The treatment target for LDL-C will be ≤60 mg/dl for the triple therapy group Atorvastatin: 10 to 80 mg of atorvastatin each day Niacin: 2000 mg of niacin each day Colesevelam: 3.8 g of colesevelam each day | 3 | 73 | 20 | 73 | 32 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Stroke | General disorders | Systematic Assessment |
| ||
| Coronary artery bypass graft surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| Percutaneous coronary intervention | Cardiac disorders | Systematic Assessment | Single or multiple vessel |
| |
| Peripheral artery revascularization | Vascular disorders | Systematic Assessment |
| ||
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Hospitalized for worsening ischemia | Cardiac disorders | Systematic Assessment | Hospitalization for worsening cardiac ischemia but no revascularization |
| |
| Hospitalized for transient ischemic attack | Vascular disorders | Systematic Assessment |
| ||
| Hospitalized for heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Death - Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Death - myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Death - Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Death - Intentional self-harm | General disorders | Systematic Assessment |
| ||
| Death - Idiopathic Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Death - Other/Multiple/Unknown | General disorders | Systematic Assessment |
| ||
| Diseased or injured hip joint requiring replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New onset Type 2 Diabetes Melitus | Endocrine disorders | Systematic Assessment |
| ||
| Sinus infection | Infections and infestations | Systematic Assessment | Sinus infection with or without antibiotic use |
| |
| Muscle aches | General disorders | Systematic Assessment |
| ||
| Leg pain | General disorders | Systematic Assessment |
| ||
| Diseased or injured knee joint requiring surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Dizziness | General disorders | Systematic Assessment |
| ||
| Kidney stone | Renal and urinary disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Angina | Cardiac disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xue-Qiao Zhao | University of Washington | 206-744-8305 | xueqiao@uw.edu |
| Dec 3, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002340 | Carotid Artery Diseases |
| D050197 | Atherosclerosis |
| D058226 | Plaque, Atherosclerotic |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D009525 | Niacin |
| D000069472 | Colesevelam Hydrochloride |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D000499 | Allylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000498 | Allyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
Participants will receive atorvastatin, niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the double therapy group.
Atorvastatin: 10 to 80 mg of atorvastatin each day
Niacin: 2000 mg of niacin each day
Placebo Colesevelam: Placebo colesevelam each day
| OG002 | 3 - Triple Therapy Group | Participants will receive atorvastatin, niacin, and colesevelam. The treatment target for LDL-C will be ≤60 mg/dl for the triple therapy group Atorvastatin: 10 to 80 mg of atorvastatin each day Niacin: 2000 mg of niacin each day Colesevelam: 3.8 g of colesevelam each day |
|
|