Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065806
Status:
COMPLETED
Last Update Posted:
2013-08-15
First Post:
2003-08-01
Brief Title:
Atherosclerosis Prevention in Pediatric Lupus Erythematosus APPLE
Sponsor:
Laura Schanberg
Organization:
Duke University
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Study to Test the Safety and Efficacy of Lipitor Atorvastatin in Reducing the Progression of Carotid IMT in Early Childhood SLE
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is
1 To assess the efficacy of a lipid-lowering agent atorvastatin on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood
2 To assess the safety of intermediate-term 36 months treatment of children and young adults with atorvastatin
3 To further characterize the course of SLE in children and young adults by establishing a cohort of pediatric SLE patients to be followed prospectively
4 To establish a mechanism for conducting clinical trials in rare pediatric rheumatic diseases using the Childrens Arthritis and Rheumatology Research Alliance CARRA
1 To assess the efficacy of a lipid-lowering agent atorvastatin on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood
2 To assess the safety of intermediate-term 36 months treatment of children and young adults with atorvastatin
3 To further characterize the course of SLE in children and young adults by establishing a cohort of pediatric SLE patients to be followed prospectively
4 To establish a mechanism for conducting clinical trials in rare pediatric rheumatic diseases using the Childrens Arthritis and Rheumatology Research Alliance CARRA
Detailed Description:
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 Lpa carotid intima media thickness IMT and tensor diffusionMRI
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 Lpa carotid intima media thickness IMT and tensor diffusionMRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01 AR022265 | None | None | None |
| NIAMS-090 | None | None | None |