Trial Outcomes & Findings for Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) (NCT NCT00065806)
NCT ID: NCT00065806
Last Updated: 2013-08-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
221 participants
Primary outcome timeframe
Change from baseline to 36 months
Results posted on
2013-08-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
108
|
|
Overall Study
COMPLETED
|
93
|
89
|
|
Overall Study
NOT COMPLETED
|
20
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)
Baseline characteristics by cohort
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
87 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
15.7 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
15.8 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
15.7 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 36 monthsFor 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.
Outcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Mean-Mean Common Carotid IMT (CIMT)
|
0.0010 mm
Interval -0.0006 to 0.0026
|
0.0024 mm
Interval 0.0007 to 0.004
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsFor 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.
Outcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Mean-Max CIMT
|
0.0037 mm
Interval 0.0015 to 0.0058
|
0.0064 mm
Interval 0.0042 to 0.0086
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsFor 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.
Outcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Mean-Mean CIMT
|
0.0033 mm
Interval 0.0018 to 0.0047
|
0.0049 mm
Interval -0.0034 to 0.0063
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsFor 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.
Outcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Mean-Max Common CIMT
|
0.0006 mm
Interval -0.0018 to 0.003
|
0.0008 mm
Interval -0.0017 to 0.003
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsFor 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.
Outcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Mean-Max Internal CIMT
|
0.0090 mm
Interval 0.0052 to 0.0128
|
0.0144 mm
Interval 0.0106 to 0.0182
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsFor 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.
Outcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Mean-Mean Internal CIMT
|
0.0067 mm
Interval 0.0041 to 0.0093
|
0.0082 mm
Interval 0.0056 to 0.0109
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsFor 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.
Outcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Mean-Max Bifurcation CIMT
|
0.0033 mm
Interval 0.0001 to 0.0064
|
0.0072 mm
Interval 0.004 to 0.0104
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsFor 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.
Outcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Mean-Mean Bifurcation CIMT
|
0.0030 mm
Interval 0.0009 to 0.005
|
0.0055 mm
Interval 0.0035 to 0.0076
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsFor 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.
Outcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Mean-Max Far Wall CIMT
|
0.0045 mm
Interval 0.0019 to 0.0072
|
0.0082 mm
Interval 0.0055 to 0.011
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsFor 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.
Outcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Mean-Mean Far Wall CIMT
|
0.0042 mm
Interval 0.0025 to 0.0059
|
0.0064 mm
Interval 0.0047 to 0.0081
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsFor 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.
Outcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Mean-Max Near Wall CIMT
|
0.0024 mm
Interval -0.0003 to 0.005
|
0.0038 mm
Interval 0.0011 to 0.0066
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsFor 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.
Outcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Mean-Mean Near Wall CIMT
|
0.0022 mm
Interval 0.0002 to 0.0041
|
0.0028 mm
Interval 0.0008 to 0.0047
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsOutcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Natural Log of mg/L for hsCRP
|
-0.13 natural log of mg/L
Interval -0.48 to 0.22
|
0.27 natural log of mg/L
Interval -0.08 to 0.63
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsOutcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Total Cholesterol
|
-30.30 mg/dl
Interval -37.06 to -23.53
|
-0.72 mg/dl
Interval -7.57 to 6.12
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsOutcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in HDL Cholesterol
|
-0.43 mg/dl
Interval -2.23 to 1.37
|
0.89 mg/dl
Interval -0.93 to 2.71
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsOutcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in LDL Cholesterol
|
-27.63 mg/dl
Interval -32.79 to -22.47
|
-1.48 mg/dl
Interval -6.72 to 3.76
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsOutcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Triglycerides
|
-11.04 mg/dl
Interval -23.24 to 1.17
|
-5.62 mg/dl
Interval -17.99 to 6.75
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsOutcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Lipoprotein A
|
2.00 mg/dl
Interval -2.17 to 6.17
|
6.34 mg/dl
Interval 2.09 to 10.59
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsOutcome measures
| Measure |
1 Atorvastatin
n=113 Participants
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.
|
2 Placebo
n=108 Participants
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.
|
|---|---|---|
|
Change in Homocysteine
|
1.84 μmoles/liter
Interval 1.08 to 2.6
|
1.76 μmoles/liter
Interval 0.98 to 2.53
|
Adverse Events
1 Atorvastatin
Serious events: 34 serious events
Other events: 94 other events
Deaths: 0 deaths
2 Placebo
Serious events: 40 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 Atorvastatin
n=113 participants at risk
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.
|
2 Placebo
n=108 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Herpes Zoster
|
0.88%
1/113 • Number of events 1
|
4.6%
5/108 • Number of events 5
|
|
Infections and infestations
Pneumonia
|
3.5%
4/113 • Number of events 5
|
0.93%
1/108 • Number of events 5
|
|
Infections and infestations
Appendicitis
|
0.88%
1/113 • Number of events 1
|
0.93%
1/108 • Number of events 2
|
|
Infections and infestations
Gastroeneritis
|
1.8%
2/113 • Number of events 2
|
0.00%
0/108
|
|
Infections and infestations
Gastroenteritis Viral
|
1.8%
2/113 • Number of events 2
|
0.00%
0/108
|
|
Infections and infestations
Sinusitis
|
1.8%
2/113 • Number of events 2
|
0.00%
0/108
|
|
Infections and infestations
Viral Infection
|
1.8%
2/113 • Number of events 2
|
0.00%
0/108
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Cervicitis Trichomonal
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Infections and infestations
Clostridial Infection
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Meningitis Aseptic
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Meningitis Viral
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Peritonitis Bacterial
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Infections and infestations
Pneumonia Streptococcal
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Streptococcal Sepsis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
8.8%
10/113 • Number of events 13
|
7.4%
8/108 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Arthraligia
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Psychiatric disorders
Suicidal Ideation
|
0.88%
1/113 • Number of events 1
|
1.9%
2/108 • Number of events 2
|
|
Psychiatric disorders
Depression
|
1.8%
2/113 • Number of events 2
|
0.00%
0/108
|
|
Psychiatric disorders
Pscyhotic Disorder
|
0.00%
0/113
|
1.9%
2/108 • Number of events 2
|
|
Psychiatric disorders
Drug Dependence
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Psychiatric disorders
Hallucination, Visual
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Psychiatric disorders
Mental Status Changes
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Nervous system disorders
Convulsion
|
0.00%
0/113
|
2.8%
3/108 • Number of events 3
|
|
Nervous system disorders
Headache
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Psychiatric disorders
Lupus Encephalitis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Nervous system disorders
Migraine
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Nervous system disorders
Myelitis Transverse
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Renal and urinary disorders
Lupus Nephritis
|
0.88%
1/113 • Number of events 1
|
2.8%
3/108 • Number of events 3
|
|
Renal and urinary disorders
Glomerulonephritis Acute
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.88%
1/113 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.88%
1/113 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Skin and subcutaneous tissue disorders
Uticaria
|
0.88%
1/113 • Number of events 1
|
2.8%
3/108 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.88%
1/113 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.8%
2/113 • Number of events 3
|
0.93%
1/108 • Number of events 5
|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic Purpura
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
General disorders
Adverse Drug Reaction
|
0.88%
1/113 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
|
General disorders
Infusion Related Reaction
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/113
|
1.9%
2/108 • Number of events 2
|
|
Metabolism and nutrition disorders
Gestational Diabetes
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Pregnancy, puerperium and perinatal conditions
Abortion, Spontaneous
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Pregnancy, puerperium and perinatal conditions
Foetal Cardiac Disorder
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Vascular disorders
Hypertension
|
0.88%
1/113 • Number of events 1
|
1.9%
2/108 • Number of events 2
|
|
Cardiac disorders
Pericardial Effusion
|
0.88%
1/113 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
|
Congenital, familial and genetic disorders
Sickle Cell Anaemia with Crisis
|
0.88%
1/113 • Number of events 5
|
0.93%
1/108 • Number of events 4
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Immune system disorders
Serum Sickness
|
0.00%
0/113
|
1.9%
2/108 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytosis haematophagic
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/113
|
0.93%
1/108 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
|
Investigations
Muscle Enzyme Increased
|
0.88%
1/113 • Number of events 1
|
0.00%
0/108
|
Other adverse events
| Measure |
1 Atorvastatin
n=113 participants at risk
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.
|
2 Placebo
n=108 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Sinusitis
|
9.7%
11/113 • Number of events 15
|
6.5%
7/108 • Number of events 11
|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
8/113 • Number of events 11
|
9.3%
10/108 • Number of events 16
|
|
Infections and infestations
Herpes Zoster
|
3.5%
4/113 • Number of events 5
|
11.1%
12/108 • Number of events 12
|
|
Infections and infestations
Bronchitis
|
5.3%
6/113 • Number of events 7
|
2.8%
3/108 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.8%
10/113 • Number of events 12
|
9.3%
10/108 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
8.8%
10/113 • Number of events 14
|
7.4%
8/108 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.0%
9/113 • Number of events 10
|
4.6%
5/108 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
4.4%
5/113 • Number of events 9
|
5.6%
6/108 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
5.3%
6/113 • Number of events 6
|
2.8%
3/108 • Number of events 3
|
|
Nervous system disorders
Neurotoxicity
|
23.9%
27/113 • Number of events 62
|
23.1%
25/108 • Number of events 51
|
|
Nervous system disorders
Headache
|
6.2%
7/113 • Number of events 9
|
6.5%
7/108 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.8%
19/113 • Number of events 28
|
25.9%
28/108 • Number of events 47
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
8.8%
10/113 • Number of events 14
|
7.4%
8/108 • Number of events 8
|
|
Investigations
Alanine Aminotransferase Increased
|
7.1%
8/113 • Number of events 10
|
8.3%
9/108 • Number of events 11
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
7.1%
8/113 • Number of events 14
|
6.5%
7/108 • Number of events 11
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.3%
6/113 • Number of events 8
|
4.6%
5/108 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.5%
4/113 • Number of events 6
|
7.4%
8/108 • Number of events 8
|
|
General disorders
Non-Cardiac Chest Pain
|
5.3%
6/113 • Number of events 7
|
3.7%
4/108 • Number of events 4
|
|
General disorders
Fatigue
|
1.8%
2/113 • Number of events 2
|
5.6%
6/108 • Number of events 6
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.1%
8/113 • Number of events 13
|
5.6%
6/108 • Number of events 9
|
|
Renal and urinary disorders
Proteinuria
|
10.6%
12/113 • Number of events 19
|
7.4%
8/108 • Number of events 11
|
|
Vascular disorders
Hypertension
|
11.5%
13/113 • Number of events 30
|
11.1%
12/108 • Number of events 25
|
|
Eye disorders
Conjunctivitis
|
1.8%
2/113 • Number of events 2
|
5.6%
6/108 • Number of events 6
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
13.3%
15/113 • Number of events 17
|
16.7%
18/108 • Number of events 24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs agree to follow the CARRA Publication Guidelines. https://www.carragroup.org/about-carra/carra-policies/carra-endorsed-studies-policies
- Publication restrictions are in place
Restriction type: OTHER