Multicenter, Prospective, Randomized, Controlled, Double-blind Trial on the Impact of Rosuvastatin on Subclinical Markers of Atherosclerosis in Patients With Primary Necrotizing Vasculitides "STATVAS"

Recruiting

Phase 3 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • Rosuvastatin (Crestor)Drug
    Intervention Desc: Rosuvastatin 20 mg/day
    ARM 1: Kind: Experimental
    Label: Group I
    Description: Rosuvastatin 20 mg/day
  • Placebo Drug
    Intervention Desc: Placebo
    ARM 1: Kind: Experimental
    Label: Group II
    Description: Placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Rate of change in mean carotid intima-media thickness for 12 predefined sites 24 months No
Secondary Rate of change in endothelial function with brachial artery flow-mediated dilatation 24 months No
Secondary Rate of change in the number of plaques in three peripheral vessels (carotid and femoral arteries and abdominal aorta) 24 months No
Secondary Rate of change in serum biomarkers of subclinical atherosclerosis 24 months No
Secondary Rate of major cardiovascular events (myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes) 24 months No
Secondary Rate of change in vasculitis activity 24 months No
Secondary Rate of vasculitis relapses 24 months No
Secondary Rate of adverse events 24 months Yes
Primary Rate of change in mean carotid intima-media thickness for 6 predefined sites 24 months No
Secondary Annualized rate of change in mean carotid intima-media thickness for 6 predefined sites (distal common carotid arteries, carotid bulbs, internal carotid arteries), assessed with B-mode ultrasound 24 months No
Secondary Rate of change in lipid profile (triglycerids, total, HDL and LDL cholesterol) compared to baseline value. 24 months No
Secondary Rate of change in endothelial function with brachial artery flow-mediated dilatation compared to baseline value 24 months No
Secondary Rate of change in lipid profile (triglycerids, total, HDL and LDL cholesterol) compared to baseline value. 24 months No
Secondary Rate of change in endothelial function with brachial artery flow-mediated dilatation compared to baseline value 24 months No

Sponsors