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| ID | Type | Description | Link |
|---|---|---|---|
| NIAMS-090 | |||
| N01AR022265 | U.S. NIH Grant/Contract | View source |
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The purpose of this study is:
Children and adolescents with SLE represent 15% of all SLE patients. Children with SLE suffer high morbidity that affects many organ systems, reduces their quality of life, and shortens their lifespan. As more children with SLE survive into adulthood, atherosclerotic cardiovascular disease has emerged as a major concern. SLE is a significant risk factor for myocardial infarction and death in young premenopausal women with SLE, even after controlling for traditional cardiovascular risk factors. Acceleration of atherogenesis in SLE most likely reflects SLE-associated vascular immune and inflammatory changes.
Although limited, the data on cardiovascular and lipid abnormalities in children with SLE implicate atherosclerosis as an important cause of long-term morbidity and mortality. The 3-hydroxy-3-methlglutaryl-coenzyme A (HMG CoA) reductase inhibitors, or statins, reduce mortality and morbidity from atherosclerosis in adults and have intrinsic anti-inflammatory and immune modulatory properties. These anti-inflammatory and immune modulatory activities may have particular benefit in the prevention and treatment of atherosclerosis in SLE. This trial will evaluate atorvastatin in children with SLE in the largest cohort of pediatric SLE patients ever studied prospectively.
Children in this study will be randomized to receive either atorvastatin or a placebo. All children will be followed for 3 years, during which they will have 15 study visits. Study visits will generally last 2 hours and will include medical interview, medication review and pill count, physical examination, and blood and urine tests. Cardiovascular-specific outcome measures will include assessments of high sensitivity CRP; fasting lipid profile; homocysteine level; apolipoprotein A, B1, and Lp(a); carotid intima media thickness (IMT); and tensor diffusion/MRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi\]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months. |
|
| 2 | Placebo Comparator | Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi\]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean-Mean Common Carotid IMT (CIMT) | For the common carotid arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right common near wall mean, right common far wall mean, left common near wall mean and left common far wall mean). These summary variables were then averaged to estimate a single mean-mean common CIMT for each participant visit. | Change from baseline to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean-Max CIMT | For each side, segment and wall, the maximum CIMT over the 4 angles of interrogation was selected to produce 12 summary variables (right common near wall max, right common far wall max, right bifurcation near wall max, right bifurcation far wall max, right internal near wall max, right internal far wall max, left common near wall max, left common far wall max, left bifurcation near wall max, left bifurcation far wall max, left internal near wall max and left internal far wall max). These 12 summary variables were then averaged to estimate a single mean-max CIMT for each participant visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura E. Schanberg, MD | Duke Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Medical Center / Duke Clinical Research Institute | Durham | North Carolina | 27715 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25902709 | Derived | Gurion R, Tangpricha V, Yow E, Schanberg LE, McComsey GA, Robinson AB; Atherosclerosis Prevention in Pediatric Lupus Erythematosus Investigators. Avascular necrosis in pediatric systemic lupus erythematosus: a brief report and review of the literature. Pediatr Rheumatol Online J. 2015 Apr 23;13:13. doi: 10.1186/s12969-015-0008-x. | |
| 25396067 | Derived | Robinson AB, Tangpricha V, Yow E, Gurion R, Schanberg LE, McComsey GA; APPLE Investigators. Vitamin D status is a determinant of atorvastatin effect on carotid intima medial thickening progression rate in children with lupus: an Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) substudy. Lupus Sci Med. 2014 Sep 10;1(1):e000037. doi: 10.1136/lupus-2014-000037. eCollection 2014. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Atorvastatin | Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi\]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months. Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months. |
| FG001 | 2 Placebo | Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi\]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months. Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Atorvastatin | Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi\]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months. Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months. |
| 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 |
| 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 in Mean-Mean Common Carotid IMT (CIMT) | For the common carotid arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right common near wall mean, right common far wall mean, left common near wall mean and left common far wall mean). These summary variables were then averaged to estimate a single mean-mean common CIMT for each participant visit. | Posted | Mean | 95% Confidence Interval | mm | Change from baseline to 36 months |
|
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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 Atorvastatin | Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi\]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months. Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes Zoster | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Schanberg, MD | Duke University Medical Center | 919-684-6575 | laura.schanberg@duke.edu |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Placebo atorvastatin | Drug | Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months. |
|
| Change from baseline to 36 months |
| Change in Mean-Mean CIMT | For each side, segment and wall, mean CIMT values were averaged over the 4 angles of interrogation to produce 12 summary variables (right common near wall mean, right common far wall mean, right bifurcation near wall mean, right bifurcation far wall mean, right internal near wall mean, right internal far wall mean, left common near wall mean, left common far wall mean, left bifurcation near wall mean, left bifurcation far wall mean, left internal near wall mean and left internal far wall mean). These 12 summary variables were then averaged to estimate a single mean-mean CIMT for each participant visit. | Change from baseline to 36 months |
| Change in Mean-Max Common CIMT | For each side and wall of the common carotid arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right common near wall max, right common far wall max, left common near wall max and left common far wall max). These summary variables were then averaged to estimate a single mean-max common CIMT for each participant visit. | Change from baseline to 36 months |
| Change in Mean-Max Internal CIMT | For each side and wall of the internal carotid arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right internal near wall max, right internal far wall max, left internal near wall max and left internal far wall max). These summary variables were then averaged to estimate a single mean-max internal CIMT for each participant visit. | Change from baseline to 36 months |
| Change in Mean-Mean Internal CIMT | For the internal carotid arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right internal near wall mean, right internal far wall mean, left internal near wall mean and left internal far wall mean). These summary variables were then averaged to estimate a single mean-mean internal CIMT for each participant visit. | Change from baseline to 36 months |
| Change in Mean-Max Bifurcation CIMT | For each side and wall of the bifurcation arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right bifurcation near wall max, right bifurcation far wall max, left bifurcation near wall max and left bifurcation far wall max). These summary variables were then averaged to estimate a single mean-max bifurcation CIMT for each participant visit. | Change from baseline to 36 months |
| Change in Mean-Mean Bifurcation CIMT | For the bifurcation arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right bifurcation near wall mean, right bifurcation far wall mean, left bifurcation near wall mean and left bifurcation far wall mean). These summary variables were then averaged to estimate a single mean-mean bifurcation CIMT for each participant visit. | Change from baseline to 36 months |
| Change in Mean-Max Far Wall CIMT | For the far wall measurements for each side and segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 6 summary variables (right common far wall max, right bifurcation far wall max, right internal far wall max, left common far wall max, left bifurcation far wall max, and left internal far wall max). These 6 summary variables were then averaged to estimate a single mean-max far wall CIMT for each participant visit. | Change from baseline to 36 months |
| Change in Mean-Mean Far Wall CIMT | For the far wall measurements for each side and segment, mean CIMT values were averaged over the 4 angles of interrogation to produce 6 summary variables (right common far wall mean, right bifurcation far wall mean, right internal far wall mean, left common far wall mean, left bifurcation far wall mean and left internal far wall mean). These 6 summary variables were then averaged to estimate a single mean-mean far wall CIMT for each participant visit. | Change from baseline to 36 months |
| Change in Mean-Max Near Wall CIMT | For the near wall measurements for each side and segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 6 summary variables (right common near wall max, right bifurcation near wall max, right internal near wall max, left common near wall max, left bifurcation near wall max, and left internal near wall max). These 6 summary variables were then averaged to estimate a single mean-max near wall CIMT for each participant visit. | Change from baseline to 36 months |
| Change in Mean-Mean Near Wall CIMT | For the near wall measurements for each side and segment, mean CIMT values were averaged over the 4 angles of interrogation to produce 6 summary variables (right common near wall mean, right bifurcation near wall mean, right internal near wall mean, left common near wall mean, left bifurcation wall mean and left internal far wall mean). These 6 summary variables were then averaged to estimate a single mean-mean far wall CIMT for each participant visit. | Change from baseline to 36 months |
| Change in Natural Log of mg/L for hsCRP | Change from baseline to 36 months |
| Change in Total Cholesterol | Change from baseline to 36 months |
| Change in HDL Cholesterol | Change from baseline to 36 months |
| Change in LDL Cholesterol | Change from baseline to 36 months |
| Change in Triglycerides | Change from baseline to 36 months |
| Change in Lipoprotein A | Change from baseline to 36 months |
| Change in Homocysteine | Change from baseline to 36 months |
| 25396060 | Derived | Robinson AB, Tangpricha V, Yow E, Gurion R, McComsey GA, Schanberg LE; APPLE Investigators. Vitamin D deficiency is common and associated with increased C-reactive protein in children and young adults with lupus: an Atherosclerosis Prevention in Pediatric Lupus Erythematosus substudy. Lupus Sci Med. 2014 Apr 30;1(1):e000011. doi: 10.1136/lupus-2014-000011. eCollection 2014. |
| 23436914 | Derived | Ardoin SP, Schanberg LE, Sandborg CI, Barnhart HX, Evans GW, Yow E, Mieszkalski KL, Ilowite NT, Eberhard A, Imundo LF, Kimura Y, Levy D, von Scheven E, Silverman E, Bowyer SL, Punaro L, Singer NG, Sherry DD, McCurdy DK, Klein-Gitelman M, Wallace C, Silver RM, Wagner-Weiner L, Higgins GC, Brunner HI, Jung L, Soep JB, Reed AM, Thompson SD; APPLE investigators. Secondary analysis of APPLE study suggests atorvastatin may reduce atherosclerosis progression in pubertal lupus patients with higher C reactive protein. Ann Rheum Dis. 2014 Mar;73(3):557-66. doi: 10.1136/annrheumdis-2012-202315. Epub 2013 Feb 22. |
| 22031171 | Derived | Schanberg LE, Sandborg C, Barnhart HX, Ardoin SP, Yow E, Evans GW, Mieszkalski KL, Ilowite NT, Eberhard A, Imundo LF, Kimura Y, von Scheven E, Silverman E, Bowyer SL, Punaro M, Singer NG, Sherry DD, McCurdy D, Klein-Gitelman M, Wallace C, Silver R, Wagner-Weiner L, Higgins GC, Brunner HI, Jung L, Soep JB, Reed AM, Provenzale J, Thompson SD; Atherosclerosis Prevention in Pediatric Lupus Erythematosus Investigators. Use of atorvastatin in systemic lupus erythematosus in children and adolescents. Arthritis Rheum. 2012 Jan;64(1):285-96. doi: 10.1002/art.30645. |
| 19404953 | Derived | Schanberg LE, Sandborg C, Barnhart HX, Ardoin SP, Yow E, Evans GW, Mieszkalski KL, Ilowite NT, Eberhard A, Levy DM, Kimura Y, von Scheven E, Silverman E, Bowyer SL, Punaro L, Singer NG, Sherry DD, McCurdy D, Klein-Gitelman M, Wallace C, Silver R, Wagner-Weiner L, Higgins GC, Brunner HI, Jung L, Soep JB, Reed A; Atherosclerosis Prevention in Pediatric Lupus Erythematosus Investigators. Premature atherosclerosis in pediatric systemic lupus erythematosus: risk factors for increased carotid intima-media thickness in the atherosclerosis prevention in pediatric lupus erythematosus cohort. Arthritis Rheum. 2009 May;60(5):1496-507. doi: 10.1002/art.24469. |
| BG001 | 2 Placebo | Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi\]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months. Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 2 Placebo | Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi\]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months. Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months. |
|
|
| Secondary | Change in Mean-Max CIMT | For each side, segment and wall, the maximum CIMT over the 4 angles of interrogation was selected to produce 12 summary variables (right common near wall max, right common far wall max, right bifurcation near wall max, right bifurcation far wall max, right internal near wall max, right internal far wall max, left common near wall max, left common far wall max, left bifurcation near wall max, left bifurcation far wall max, left internal near wall max and left internal far wall max). These 12 summary variables were then averaged to estimate a single mean-max CIMT for each participant visit. | Posted | Mean | 95% Confidence Interval | mm | Change from baseline to 36 months |
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| Secondary | Change in Mean-Mean CIMT | For each side, segment and wall, mean CIMT values were averaged over the 4 angles of interrogation to produce 12 summary variables (right common near wall mean, right common far wall mean, right bifurcation near wall mean, right bifurcation far wall mean, right internal near wall mean, right internal far wall mean, left common near wall mean, left common far wall mean, left bifurcation near wall mean, left bifurcation far wall mean, left internal near wall mean and left internal far wall mean). These 12 summary variables were then averaged to estimate a single mean-mean CIMT for each participant visit. | Posted | Mean | 95% Confidence Interval | mm | Change from baseline to 36 months |
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| Secondary | Change in Mean-Max Common CIMT | For each side and wall of the common carotid arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right common near wall max, right common far wall max, left common near wall max and left common far wall max). These summary variables were then averaged to estimate a single mean-max common CIMT for each participant visit. | Posted | Mean | 95% Confidence Interval | mm | Change from baseline to 36 months |
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| Secondary | Change in Mean-Max Internal CIMT | For each side and wall of the internal carotid arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right internal near wall max, right internal far wall max, left internal near wall max and left internal far wall max). These summary variables were then averaged to estimate a single mean-max internal CIMT for each participant visit. | Posted | Mean | 95% Confidence Interval | mm | Change from baseline to 36 months |
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| Secondary | Change in Mean-Mean Internal CIMT | For the internal carotid arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right internal near wall mean, right internal far wall mean, left internal near wall mean and left internal far wall mean). These summary variables were then averaged to estimate a single mean-mean internal CIMT for each participant visit. | Posted | Mean | 95% Confidence Interval | mm | Change from baseline to 36 months |
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| Secondary | Change in Mean-Max Bifurcation CIMT | For each side and wall of the bifurcation arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right bifurcation near wall max, right bifurcation far wall max, left bifurcation near wall max and left bifurcation far wall max). These summary variables were then averaged to estimate a single mean-max bifurcation CIMT for each participant visit. | Posted | Mean | 95% Confidence Interval | mm | Change from baseline to 36 months |
|
|
|
| Secondary | Change in Mean-Mean Bifurcation CIMT | For the bifurcation arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right bifurcation near wall mean, right bifurcation far wall mean, left bifurcation near wall mean and left bifurcation far wall mean). These summary variables were then averaged to estimate a single mean-mean bifurcation CIMT for each participant visit. | Posted | Mean | 95% Confidence Interval | mm | Change from baseline to 36 months |
|
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| Secondary | Change in Mean-Max Far Wall CIMT | For the far wall measurements for each side and segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 6 summary variables (right common far wall max, right bifurcation far wall max, right internal far wall max, left common far wall max, left bifurcation far wall max, and left internal far wall max). These 6 summary variables were then averaged to estimate a single mean-max far wall CIMT for each participant visit. | Posted | Mean | 95% Confidence Interval | mm | Change from baseline to 36 months |
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| Secondary | Change in Mean-Mean Far Wall CIMT | For the far wall measurements for each side and segment, mean CIMT values were averaged over the 4 angles of interrogation to produce 6 summary variables (right common far wall mean, right bifurcation far wall mean, right internal far wall mean, left common far wall mean, left bifurcation far wall mean and left internal far wall mean). These 6 summary variables were then averaged to estimate a single mean-mean far wall CIMT for each participant visit. | Posted | Mean | 95% Confidence Interval | mm | Change from baseline to 36 months |
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|
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| Secondary | Change in Mean-Max Near Wall CIMT | For the near wall measurements for each side and segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 6 summary variables (right common near wall max, right bifurcation near wall max, right internal near wall max, left common near wall max, left bifurcation near wall max, and left internal near wall max). These 6 summary variables were then averaged to estimate a single mean-max near wall CIMT for each participant visit. | Posted | Mean | 95% Confidence Interval | mm | Change from baseline to 36 months |
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|
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| Secondary | Change in Mean-Mean Near Wall CIMT | For the near wall measurements for each side and segment, mean CIMT values were averaged over the 4 angles of interrogation to produce 6 summary variables (right common near wall mean, right bifurcation near wall mean, right internal near wall mean, left common near wall mean, left bifurcation wall mean and left internal far wall mean). These 6 summary variables were then averaged to estimate a single mean-mean far wall CIMT for each participant visit. | Posted | Mean | 95% Confidence Interval | mm | Change from baseline to 36 months |
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| Secondary | Change in Natural Log of mg/L for hsCRP | Posted | Mean | 95% Confidence Interval | natural log of mg/L | Change from baseline to 36 months |
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| Secondary | Change in Total Cholesterol | Posted | Mean | 95% Confidence Interval | mg/dl | Change from baseline to 36 months |
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| Secondary | Change in HDL Cholesterol | Posted | Mean | 95% Confidence Interval | mg/dl | Change from baseline to 36 months |
|
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| Secondary | Change in LDL Cholesterol | Posted | Mean | 95% Confidence Interval | mg/dl | Change from baseline to 36 months |
|
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| Secondary | Change in Triglycerides | Posted | Mean | 95% Confidence Interval | mg/dl | Change from baseline to 36 months |
|
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| Secondary | Change in Lipoprotein A | Posted | Mean | 95% Confidence Interval | mg/dl | Change from baseline to 36 months |
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| Secondary | Change in Homocysteine | Posted | Mean | 95% Confidence Interval | μmoles/liter | Change from baseline to 36 months |
|
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| 34 |
| 113 |
| 94 |
| 113 |
| EG001 | 2 Placebo | Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi\]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months. Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months. | 40 | 108 | 95 | 108 |
| Pneumonia | Infections and infestations |
|
| Appendicitis | Infections and infestations |
|
| Gastroeneritis | Infections and infestations |
|
| Gastroenteritis Viral | Infections and infestations |
|
| Sinusitis | Infections and infestations |
|
| Viral Infection | Infections and infestations |
|
| Bacteraemia | Infections and infestations |
|
| Cervicitis Trichomonal | Infections and infestations |
|
| Clostridial Infection | Infections and infestations |
|
| Infection | Infections and infestations |
|
| Meningitis Aseptic | Infections and infestations |
|
| Meningitis Viral | Infections and infestations |
|
| Peritonitis Bacterial | Infections and infestations |
|
| Pharyngitis Streptococcal | Infections and infestations |
|
| Pneumonia Streptococcal | Infections and infestations |
|
| Pyelonephritis | Infections and infestations |
|
| Pyelonephritis Acute | Infections and infestations |
|
| Streptococcal Sepsis | Infections and infestations |
|
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders |
|
| Arthraligia | Musculoskeletal and connective tissue disorders |
|
| Myositis | Musculoskeletal and connective tissue disorders |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders |
|
| Suicidal Ideation | Psychiatric disorders |
|
| Depression | Psychiatric disorders |
|
| Pscyhotic Disorder | Psychiatric disorders |
|
| Drug Dependence | Psychiatric disorders |
|
| Hallucination | Psychiatric disorders |
|
| Hallucination, Visual | Psychiatric disorders |
|
| Mental Status Changes | Psychiatric disorders |
|
| Convulsion | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Lupus Encephalitis | Psychiatric disorders |
|
| Migraine | Nervous system disorders |
|
| Myelitis Transverse | Nervous system disorders |
|
| Lupus Nephritis | Renal and urinary disorders |
|
| Glomerulonephritis Acute | Renal and urinary disorders |
|
| Renal Failure Acute | Renal and urinary disorders |
|
| Abdominal Pain | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Enteritis | Gastrointestinal disorders |
|
| Irritable Bowel Syndrome | Gastrointestinal disorders |
|
| Pancreatitis Acute | Gastrointestinal disorders |
|
| Uticaria | Skin and subcutaneous tissue disorders |
|
| Panniculitis | Skin and subcutaneous tissue disorders |
|
| Psoriasis | Skin and subcutaneous tissue disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Thrombocytopenia | Blood and lymphatic system disorders |
|
| Thrombotic Thrombocytopenic Purpura | Blood and lymphatic system disorders |
|
| Adverse Drug Reaction | General disorders |
|
| Infusion Related Reaction | General disorders |
|
| Non-Cardiac Chest Pain | General disorders |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Gestational Diabetes | Metabolism and nutrition disorders |
|
| Abortion, Spontaneous | Pregnancy, puerperium and perinatal conditions |
|
| Foetal Cardiac Disorder | Pregnancy, puerperium and perinatal conditions |
|
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions |
|
| Hypertension | Vascular disorders |
|
| Pericardial Effusion | Cardiac disorders |
|
| Sickle Cell Anaemia with Crisis | Congenital, familial and genetic disorders |
|
| Cholelithiasis | Hepatobiliary disorders |
|
| Serum Sickness | Immune system disorders |
|
| Histiocytosis haematophagic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Hepatitis | Hepatobiliary disorders |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders |
|
| Muscle Enzyme Increased | Investigations |
|
| Sinusitis | Infections and infestations |
|
| Urinary Tract Infection | Infections and infestations |
|
| Herpes Zoster | Infections and infestations |
|
| Bronchitis | Infections and infestations |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders |
|
| Myositis | Musculoskeletal and connective tissue disorders |
|
| Neurotoxicity | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Gastrointestinal Disorder | Gastrointestinal disorders |
|
| Alanine Aminotransferase Increased | Investigations |
|
| Blood Creatine Phosphokinase Increased | Investigations |
|
| Aspartate Aminotransferase Increased | Investigations |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Non-Cardiac Chest Pain | General disorders |
|
| Fatigue | General disorders |
|
| Leukopenia | Blood and lymphatic system disorders |
|
| Proteinuria | Renal and urinary disorders |
|
| Hypertension | Vascular disorders |
|
| Conjunctivitis | Eye disorders |
|
PIs agree to follow the CARRA Publication Guidelines. https://www.carragroup.org/about-carra/carra-policies/carra-endorsed-studies-policies
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |