Carotid ultrasound to guide heart disease prevention in people with inflammatory rheumatic diseases
Tests ultrasound of neck arteries to guide prevention in people with inflammatory rheumatic disease.
Plain-language title generated from the registry record
Registry title: Carotid Ultrasound-Based Strategy for Primary Prevention of Cardiovascular Events in Inflammatory Rheumatic Disease (PREVENER)
Key facts
- Where
- Barcelona, Bilbao, Ciudad Real, Córdoba, Elche, Las Palmas De Gran Canaria, Madrid, Murcia, Orihuela, Palma, San Cristóbal de La Laguna, Sant Joan d'Alacant, Santander, Torrelavega, and Vitoria, SpainSee the 17 sites
- Phase
- Phase 4
Where in Spain
- Hospital laredoSpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario BasurtoBilbao, SpainTaking people
- Hospital General Universitario de Ciudad RealCiudad Real, SpainTaking people
- Hospital Universitario Reina SofiaCórdoba, SpainTaking people
- Hospital General Universitario de ElcheElche, SpainTaking people
- El Hospital Universitario De Gran Canaria Dr. NegrinLas Palmas De Gran Canaria, SpainTaking people
- Hospital Universitario La PazMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpainTaking people
- Hospital Vega Baja de OrihuelaOrihuela, SpainTaking people
- Hospital Son LlatzerPalma, SpainTaking people
- Hospital Universitario de CanariasSan Cristóbal de La Laguna, SpainTaking people
- Hospital Universitario San Juan de AlicanteSant Joan d'Alacant, SpainTaking people
- Hospital Universitario Marqués de ValdecillaSantander, SpainTaking people
- Hospital SierrallanaTorrelavega, SpainTaking people
- Hospital Universitario ArabaVitoria, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto de Investigación Marqués de Valdecilla
- Trial code
- NCT07611747EU 2025-521086-28-00
- Record updated
- 10 November 2026
- Original description
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).Read full original descriptionShow less
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
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.
Inclusion: Patients aged ≥50 years who have provided written informed consent; 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.
Exclusion: 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).