Statin trial targets hidden heart risk in vasculitis patients
NCT ID NCT02117453
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested whether rosuvastatin, a common cholesterol-lowering drug, could reduce early signs of artery hardening in 121 people with ANCA-associated vasculitis. Participants were in remission and received either rosuvastatin or a placebo for up to 2 years. The goal was to see if the drug could lower the risk of future heart attacks or strokes in this group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rosuvastatin (a statin drug that lowers cholesterol)
- What this could lead to
- If it works, this could point toward a way to reduce heart disease risk in people with ANCA vasculitis.
- What could go wrong
- This is a completed Phase 3 trial, but the results may not show a clear benefit. Statins have known side effects like muscle pain, and the effect on heart events is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
121 people
The number who actually took part.
- Started
-
Oct 2014
- Finished
-
Nov 2019
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hopital Cochin
Paris, 75014, France
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Other studies related to the condition(s) this trial covers.
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