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Carotid Ultrasound-Based Strategy for Primary Prevention of Cardiovascular Events in Inflammatory Rheumatic Disease (PREVENER)

RecruitingPhase 4Ages 50 Years - anyAllInstituto de Investigación Marqués de Valdecilla
NCT07611747 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

PREVENER is a randomized, open-label, multicenter, phase IV clinical trial designed to evaluate the efficacy 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. However, conventional CV risk scores (SCORE2/OP) systematically underestimate this risk, leaving many high-risk patients without appropriate preventive treatment. Patients aged ≥50 years with IRD and low-to-moderate CV risk according to SCORE2/OP will be randomized 1:1 to either an experimental group (carotid ultrasound to detect subclinical atherosclerosis) or a control group (stand

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients aged ≥50 years who have provided written informed consent. 2. 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 3. Low-to-moderate cardiovascular risk according to SCORE2/OP classification. Exclusion Criteria: 1. 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. 2. Prior carotid ultrasound examination with subsequent therapeutic intervention derived from its results, either in the context of a research study or routine clinical practice. 3. 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).
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What it tests

  • Carotid Ultrasound
  • High-intensity lipid-lowering therapy
  • Standard care according to ESC 2021 guidelines
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Where

17 sites
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Universitario de Elche
Elche, Spain
Hospital Vega Baja de Orihuela
Orihuela, Spain
Hospital Universitario Vall d'Hebrón
Barcelona, Spain
Hospital de Laredo
Laredo, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital Sierrallana
Torrelavega, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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