EligibleTrials
Conditions › Lupus › NCT07611747

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

Recruiting · NCT07611747 · Interventional (participants receive a specific treatment) · Lead sponsor: Instituto de Investigación Marqués de Valdecilla

View the official record on ClinicalTrials.gov →
LupusRheumatoid arthritisPsoriasis

Interventions studied

Carotid UltrasoundHigh-intensity lipid-lowering therapyStandard care according to ESC 2021 guidelines

What this trial is about

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.

Who can take part

Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)

Inclusion criteria

Exclusion criteria

Where it is running

34 locations listed.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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