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

Recruiting now · Phase 4

Conditions studied: Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Axial Spondy, Systemic Lupus Erythematosus (SLE), Caridovascular Disease, Atherosclerosis, Carotid Artery Diseases

In brief

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.

Key facts

Study ID

NCT07611747

Run by

Instituto de Investigación Marqués de Valdecilla

People needed

1944

Starts

2026-04-22

Expected to finish

2031-12-01

Last updated by the study team

2026-05-28

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Hospital General Universitario de Alicante — Alicante, Alicante, Spain (enrolling)
• Hospital Vega Baja de Orihuela — Orihuela, Alicante, Spain (enrolling)
• Hospital Universitario Vall d'Hebrón — Barcelona, Barcelona, Spain (enrolling)
• Hospital de Laredo — Laredo, Cantabria, Spain (enrolling)
• Hospital Sierrallana — Torrelavega, Cantabria, Spain (enrolling)
• Hospital Universitario de Basurto — Bilbao, Vizcaya, Spain (enrolling)
• Hospital Universitario Araba — Vitoria-Gasteiz, Álava, Spain (enrolling)
• Hospital General Universitario de Ciudad Real — Ciudad Real, Ciudad Real, Spain
• Hospital Universitario Reina Sofía — Córdoba, Córdoba, Spain
• Hospital Universitari Son LLàtzer — Palma, Isla Baleares, Spain
• Hospital Universitario de Gran Canaria Dr. Negrín — Las Palmas de Gran Canaria, Las Palmas, Spain
• Hospital Universitario de Elche — Elche, Alicante, Spain
• Hospital Universitario La Paz — Madrid, Madrid, Spain
• Hospital Universitario Ramón y Cajal — Madrid, Madrid, Spain
• Hispital Universitario Virgen de la Arrixaca — Murcia, Murcia, Spain
• Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain
• Hospital Universitario de Canarias — San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain

Full record on ClinicalTrials.gov

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