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

NCT07611747 | Recruiting Phase 4

• 2 other identifiers: PREVENER2025-521086-28-00
• Study Type: interventional
• Target: 1,944
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Rheumatoid Arthritis (RA); Psoriatic Arthritis (PsA); Axial Spondy; Systemic Lupus Erythematosus (SLE); Caridovascular Disease; Atherosclerosis; Carotid Artery Diseases

Keywords

Carotid ultrasound; Carotid plaques; Subclinical atherosclerosis; Cardiovascular prevention; Inflammatory rheumatic diseases

Outcome Measures

Primary Outcomes (1)

• Incidence of Major Adverse Cardiovascular Events (MACE)

  48 months

Secondary Outcomes (8)

• Number of Participants Experiencing an Acute Myocardial Infarction or Stroke

  48 months

• Number of Participants Hospitalized for Unstable Angina

  48 months

• Number of Participants Requiring Arterial Revascularization for Peripheral Arterial Disease

  48 months

• Number of Participants Experiencing Cardiovascular Death

  48 months

• Number of Participants Experiencing a Major Cardiovascular Event. Stratified by Rheumatic Disease Subgroup

  48 months

Study Arms (2)

Experimental Group: Carotid Ultrasound

EXPERIMENTAL

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.

Diagnostic Test: Carotid Ultrasound; Drug: High-intensity lipid-lowering therapy

Control Group: Standard Care

ACTIVE COMPARATOR

Patients are managed according to standard ESC 2021 cardiovascular prevention guidelines throughout the study, without carotid ultrasound assessment.

Other: Standard care according to ESC 2021 guidelines

Interventions

Carotid Ultrasound DIAGNOSTIC_TEST

Carotid ultrasound performed to detect subclinical atherosclerosis (carotid plaques) according to Manheim consensus criteria. The presence of carotid plaques triggers reclassification to very high cardiovascular risk and initiation of high-intensity lipid-loqering therapy

Experimental Group: Carotid Ultrasound

High-intensity lipid-lowering therapy DRUG

Sequential lipid-lowering therapy initiated in experimental group patinets with carotid plaques, targeting LDL \< 55 mg/dL. Treatment includes high-intensity statins (atorvastatin 40-80mg, rouvastatin 20-40mg), with possible addition of azetimibe, bempedoic acid, and/or PCSK9 inhibitors if target is not achieved.

Experimental Group: Carotid Ultrasound

Standard care according to ESC 2021 guidelines OTHER

Lipid-lowerin treatment indicated and managed according to ESC 2021 cardiovascular prevention guidelines, based on SCORE/OP risk stratification, without carotid ultrasound assessment

Control Group: Standard Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

Study Sites (17)

Hospital General Universitario de Alicante

Alicante, Alicante, Spain

RECRUITING

Hospital Universitario de Elche

Elche, Alicante, Spain

NOT YET RECRUITING

Hospital Vega Baja de Orihuela

Orihuela, Alicante, Spain

RECRUITING

Hospital Universitario Vall d'Hebrón

Barcelona, Barcelona, Spain

RECRUITING

Hospital de Laredo

Laredo, Cantabria, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

NOT YET RECRUITING

Hospital Sierrallana

Torrelavega, Cantabria, Spain

RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, Ciudad Real, Spain

NOT YET RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

NOT YET RECRUITING

Hospital Universitari Son LLàtzer

Palma, Isla Baleares, Spain

NOT YET RECRUITING

Hospital Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

NOT YET RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, Spain

NOT YET RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

NOT YET RECRUITING

Hispital Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain

NOT YET RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain

NOT YET RECRUITING

Hospital Universitario de Basurto

Bilbao, Vizcaya, Spain

RECRUITING

Hospital Universitario Araba

Vitoria-Gasteiz, Álava, Spain

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Lupus Erythematosus, Systemic; Atherosclerosis; Carotid Artery Diseases

Interventions

Ultrasonography, Carotid Arteries

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 28, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): April 22, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (17)