Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 4: testing High-intensity lipid-lowering therapy for Rheumatoid Arthritis (RA)
PREVENER is a randomly assigned, open-label, multicenter, phase IV clinical trial designed to measure the how well it works and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD). Patients with IRD, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and systemic lupus erythematosus (SLE), have a 50% higher risk of cardiovascular (CV) events compared to the general population.
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Carotid Ultrasound, High-intensity lipid-lowering therapy, or Standard care according to ESC 2021 guidelines. The registry lists allocation as randomized. PREVENER is a randomly assigned, open-label, multicenter, phase IV clinical trial designed to measure the how well it works and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD).
They plan to enroll about 1,944 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Randomized Clinical Trial to Assess the Efficacy and Safety of a Primary Prevention Strategy for Cardiovascular Events in Patients With Inflammatory Rheumatic Diseases Based on the Use of Carotid Ultrasound
Interventions: Carotid Ultrasound, High-intensity lipid-lowering therapy, Standard care according to ESC 2021 guidelines
Primary outcome (registry wording): Incidence of Major Adverse Cardiovascular Events (MACE)
Who it is for (from inclusion criteria)
Ages 50 Years to any
Fulfillment of classification criteria for at least one of the following inflammatory rheumatic diseases:
Rheumatoid arthritis (RA) according to ACR/EULAR 2010 criteria
Psoriatic arthritis (PsA) according to CASPAR criteria
Axial spondyloarthritis (AxSpA) according to ASAS criteria
Systemic lupus erythematosus (SLE) according to ACR/EULAR 2019 criteria
Low-to-moderate cardiovascular risk according to SCORE2/OP classification
Who the registry excludes
Presence of previous cardiovascular events, type 2 diabetes mellitus, familial hypercholesterolemia, or chronic kidney disease resulting in classification as high or very high cardiovascular risk
Prior carotid ultrasound examination with subsequent therapeutic intervention derived from its results, either in the context of a research study or routine clinical practice
Contraindications to lipid-lowering therapy, including recent history of alcoholism, active liver disease, or unexplained and persistent elevation of serum transaminases exceeding three times the upper limit of normal (applicable to statins and ezetimibe)
Contact
No central phone on the registry card. Use the official listing to reach a site.
Sites listed on ClinicalTrials.gov
17 listed
Hospital General Universitario de Alicante — Alicante, Alicante, Spain (recruiting)
Hospital Universitario de Elche — Elche, Alicante, Spain (not_yet_recruiting)
Hospital Vega Baja de Orihuela — Orihuela, Alicante, Spain (recruiting)
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.
Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue disorders. This study will allow researchers to admit and follow patients suffering from autoimmune diseases of the kidney.
This study wants to obtain biologic materials from the blood, airways and/or urine of normal individuals and individuals with lung disease. The normal are used to establish a set of normal ranges for various parameters.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07611747?
Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07611747?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.