NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07611747

RecruitingPhase 4

Sponsor: Instituto de Investigación Marqués de Valdecilla

Conditions: Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Axial Spondy, Systemic Lupus Erythematosus (SLE), Caridovascular Disease

Interventions: Carotid Ultrasound, High-intensity lipid-lowering therapy, Standard care according to ESC 2021 guidelines

Countries: Spain

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.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Patients aged ≥50 years who have provided written informed consent.
2. 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
3. Low-to-moderate cardiovascular risk according to SCORE2/OP classification.

Exclusion Criteria:

1. 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.
2. Prior carotid ultrasound examination with subsequent therapeutic intervention derived from its results, either in the context of a research study or routine clinical practice.
3. 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).

Locations (17)

Alicante, Alicante, Spain
Elche, Alicante, Spain
Orihuela, Alicante, Spain
Barcelona, Barcelona, Spain
Laredo, Cantabria, Spain
Santander, Cantabria, Spain
Torrelavega, Cantabria, Spain
Ciudad Real, Ciudad Real, Spain
Córdoba, Córdoba, Spain
Palma, Isla Baleares, Spain
Las Palmas de Gran Canaria, Las Palmas, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Murcia, Murcia, Spain
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
Bilbao, Vizcaya, Spain
Vitoria-Gasteiz, Álava, Spain