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.
Key facts
- Who runs it
- Instituto de Investigación Marqués de Valdecilla
- 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
- Trial code
- Registry title
- Carotid Ultrasound-Based Strategy for Primary Prevention of Cardiovascular Events in Inflammatory Rheumatic Disease (PREVENER)
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 1,944 people, planned
- Started
- 22 Apr 2026
- Expected to end
- Dec 2031
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Carotid Ultrasound
- High-intensity lipid-lowering therapy
- Standard care according to ESC 2021 guidelines
- Record updated
- 10 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 50 or older with an inflammatory rheumatic disease and low-to-moderate heart and blood vessel risk.
- Age
- 50 years or older.
- Sex
- All sexes can join.
- Disease stage
- Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis or systemic lupus erythematosus. Cardiovascular risk must be low to moderate by the SCORE2/OP score.
- Earlier treatment
- People who had a carotid ultrasound followed by treatment based on its results cannot join.
Main reasons for not taking part
- Previous cardiovascular events
- Type 2 diabetes, familial hypercholesterolemia or chronic kidney disease that put the person in a high or very high risk group
- Earlier carotid ultrasound with treatment based on its results
- Reasons not to take cholesterol-lowering drugs, such as recent alcoholism, active liver disease or persistently raised liver enzymes above three times the upper limit of normal
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 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
About the trial
What the trial wants to find out
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
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.
The 2 groups in the trial
- Experimental Group: Carotid UltrasoundTreatment being tested
Patients undergo carotid ultrasound within 30 days of randomization. Patients with carotid plaques are reclassified as very high cardiovascular risk and initiated on high-intensity statin therapy (LDL target \< 55 mg/dL). Patients without carotid plaques are managed according to ESC 2021 guidelines.
Treatment: Carotid Ultrasound and High-intensity lipid-lowering therapy
- Control Group: Standard CareExisting treatment, for comparison
Patients are managed according to standard ESC 2021 cardiovascular prevention guidelines throughout the study, without carotid ultrasound assessment.
Treatment: Standard care according to ESC 2021 guidelines
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Carotid ultrasound to guide heart disease prevention in people with inflammatory rheumatic diseasesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 11 November 2026.
- Record updated
- 10 November 2026