The purpose of this study is to assess whether rosuvastatin could reduce the subclinical markers of atherosclerosis and the incidence of major cardiovascular events in patients with primary necrotizing vasculitides.
Previous studies demonstrated the presence of subclinical atherosclerosis in patients with ANCA-associated systemic necrotizing vasculitis. Since statins lower levels of inflammatory proteins and cholesterol, we hypothesized that people with ANCA-associated systemic necrotizing vasculitis but without indication for statin treatment according to recommandations might benefit from statin treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
121
Rosuvastatin 20 mg/day
Placebo
Hopital Cochin
Paris, France
Mean change from baseline in mean carotid intima-media thickness for 2 predefined sites (distal common carotid arteries)
Assessed with B-mode ultrasound
Time frame: 24 months
Annualized rate of change in mean carotid intima-media thickness for 2 predefined sites (distal common carotid arteries)
Assessed with B-mode ultrasound
Time frame: 24 months
Mean change from baseline in the number of plaques in three peripheral vessels (carotid and femoral arteries and abdominal aorta) at 6, 12 and 24 months
Assessed with B-mode ultrasound
Time frame: 24 months
Mean change from baseline in serum biomarkers of subclinical atherosclerosis at 6, 12 and 24 months
ultra-sensitive CRP, VCAM-1, P-selectin, thrombomodulin
Time frame: 24 months
Rate of major cardiovascular events (myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes)
Time frame: 24 months
Rate of vasculitis relapses defined by BVAS>0
Time frame: 24 months
Rate of adverse events
Time frame: 24 months
Mean change from baseline in lipid profile (triglycerids, total, HDL and LDL cholesterol) at 6, 12 and 24 months compared to baseline value.
Time frame: 24 months
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