Condition: Rheumatoid Arthritis (RA) · Psoriatic Arthritis (PsA) · Axial Spondy · Sponsor: Instituto de Investigación Marqués de Valdecilla
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 (standard care according to ESC 2021 guidelines). Patients in the experimental group with carotid plaques will be reclassified as very high CV risk and treated with high-intensity statins (LDL target \<55 mg/dL). The primary endpoint is the incidence of major adverse cardiovascular events (MACE) over 48 months of follow-up.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| 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 |
| Hospital Universitario Vall d'Hebrón | Barcelona, Barcelona, Spain | Recruiting |
| Hospital de Laredo | Laredo, Cantabria, Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla | Santander, Cantabria, Spain | Not Yet Recruiting |
| Hospital Sierrallana | Torrelavega, Cantabria, Spain | Recruiting |
| Hospital General Universitario de Ciudad Real | Ciudad Real, Ciudad Real, Spain | Not Yet Recruiting |
| Hospital Universitario Reina Sofía | Córdoba, Córdoba, Spain | Not Yet Recruiting |
| Hospital Universitari Son LLàtzer | Palma, Isla Baleares, Spain | Not Yet Recruiting |
| Hospital Universitario de Gran Canaria Dr. Negrín | Las Palmas de Gran Canaria, Las Palmas, Spain | Not Yet Recruiting |
| Hospital Universitario La Paz | Madrid, Madrid, Spain | Not Yet Recruiting |
+ 5 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07611747