Overview

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

Status:
Completed
Trial end date:
2019-11-07
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
Rosuvastatin Calcium
Criteria
Inclusion Criteria:

Patient > 18 years. ANCA-associated vasculitis: granulomatosis with polyangiitis (GPA),
microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA,
Churg-Strauss syndrome).

Patients will fulfill the Chapel Hill Consensus Criteria and the American College of
Rheumatology criteria, in remission of vasculitis.

Patients in remission of vasculitis after induction therapy (for first flare or relapse),
including corticosteroids associated or not with immunosuppressive agents according to Good
Clinical Practice for the treatment of vasculitis, between 6 months and 10 years after the
beginning of induction therapy.

Patients with informed and signed consent

Exclusion Criteria:

Other systemic vasculitis. Secondary vasculitis (paraneoplastic or infectious). Patient
with active vasculitis after induction therapy, requiring salvage therapy.

Inability to sign informed consent. Inability to take the experimental treatment.
Hypersensitivity to rosuvastatin or to any of the excipients. Pregnancy. Chronic HCV, HBV
and/or HIV infection. Patient receiving other statin or other hypolipemic agent. Patient
requiring treatment with statin according to Afssaps recommandations published in 2005 as
primary or secondary prevention.

Subclinical atherosclerosis that confers a high cardiovascular risk before patient
randomization :

- Carotid stenosis greater than 50% in diameter

- Ectasia of the abdominal aorta

- Intima-media thickening greater than 1.2 mm

- Diffuse atherosclerosis lesions

- Heterogeneous or hypoechoic prominent plaques greater than 2 mm Participation in
another interventional study within 3 months before inclusion. Sick patients will not
be excluded if they participate simultaneously in a strictlu observational study or a
study with only blood samplings.

Any medical or psycatric disease that could prevent from administrating drugs or from
following-up the patient according the to protocol, and/or that would expose the patient to
an important number of side effects, according to the principal investigator.

Non affiliation to a social security system or any social protection system.