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

NCT02117453 | Completed Phase 3 DMC

• 2 other identifiers: P1201272013-002531-15
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

ANCA-associated Primary Necrotizing Vasculitides

Keywords

ANCA vasculitis; Statin; Subclinical markers of atherosclerosis; Cardiovascular events; Myocardial infarction; Stroke; Arterial revascularization; Unstable angina; Death

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in mean carotid intima-media thickness for 2 predefined sites (distal common carotid arteries)

  Assessed with B-mode ultrasound

  24 months

Secondary Outcomes (7)

• Annualized rate of change in mean carotid intima-media thickness for 2 predefined sites (distal common carotid arteries)

  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

  24 months

• Mean change from baseline in serum biomarkers of subclinical atherosclerosis at 6, 12 and 24 months

  24 months

• Rate of major cardiovascular events (myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes)

  24 months

• Rate of vasculitis relapses defined by BVAS>0

  24 months

Study Arms (2)

Group I

EXPERIMENTAL

Rosuvastatin 20 mg/day

Drug: Rosuvastatin

Group II

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Rosuvastatin DRUG

Rosuvastatin 20 mg/day

Group I

Placebo DRUG

Placebo

Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Any medical or psycatric disease that could prevent from administrating drugs or from following-up the patient according to the 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hopital Cochin

Paris, 75014, France

Location

MeSH Terms

Conditions

Myocardial Infarction; Stroke; Angina, Unstable; Death

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Benjamin Terrier, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Loic Guillevin, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: October 27, 2014
• Primary Completion: November 7, 2019
• Study Completion: November 7, 2019
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)