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

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ClinicalTrials.gov Identifier: NCT02117453
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment Phase
ANCA-associated Primary Necrotizing Vasculitides Drug: Rosuvastatin Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multicenter, Prospective, Randomized, Controlled, Double-blind Trial on the Impact of Rosuvastatin on Subclinical Markers of Atherosclerosis in Patients With Primary Necrotizing Vasculitides
Actual Study Start Date : October 27, 2014
Actual Primary Completion Date : November 7, 2019
Actual Study Completion Date : November 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I
Rosuvastatin 20 mg/day
Drug: Rosuvastatin
Rosuvastatin 20 mg/day

Placebo Comparator: Group II
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Rate of change in mean carotid intima-media thickness for 6 predefined sites [ Time Frame: 24 months ]
    Assessed with B-mode ultrasound


Secondary Outcome Measures :
  1. 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 [ Time Frame: 24 months ]
    Assessed with B-mode ultrasound

  2. Rate of change in the number of plaques in three peripheral vessels (carotid and femoral arteries and abdominal aorta) [ Time Frame: 24 months ]
    Assessed with B-mode ultrasound

  3. Rate of change in serum biomarkers of subclinical atherosclerosis [ Time Frame: 24 months ]
    ultra-sensitive CRP, VCAM-1, P-selectin, thrombomodulin, circulating endothelial, platelet and leucocytes microparticles

  4. Rate of major cardiovascular events (myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes) [ Time Frame: 24 months ]
  5. Rate of change in vasculitis activity [ Time Frame: 24 months ]
    BVAS

  6. Rate of vasculitis relapses [ Time Frame: 24 months ]
  7. Rate of adverse events [ Time Frame: 24 months ]
  8. Rate of change in lipid profile (triglycerids, total, HDL and LDL cholesterol) compared to baseline value. [ Time Frame: 24 months ]
  9. Rate of change in endothelial function with brachial artery flow-mediated dilatation compared to baseline value [ Time Frame: 24 months ]
    endothelial function with brachial artery flow-mediated dilatation at months 6, 12 and 24 compared to baseline value, assessed with B-mode ultrasound in a subgroup of 66 patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117453


Locations
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France
Hopital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02117453    
Other Study ID Numbers: P120127
2013-002531-15 ( EudraCT Number )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
ANCA vasculitis
Statin
Subclinical markers of atherosclerosis
Cardiovascular events
Myocardial infarction
Stroke
Arterial revascularization
Unstable angina
Death
Additional relevant MeSH terms:
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Vasculitis
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors