Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

20 maggio 2026 aggiornato da: Instituto de Investigación Marqués de Valdecilla

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

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Background:

Patients with chronic inflammatory rheumatic diseases (RA, PsA, AxSpA, SLE) carry a significantly increased risk of atherosclerotic cardiovascular events compared to the general population. This excess risk is largely attributed to the pro-atherogenic effect of chronic inflammation. Despite this, conventional CV risk stratification tools such as SCORE2/OP do not account for inflammation-related risk, leading to systematic underestimation of CV risk in these patients. Data from the CARMA project demonstrated that 53% of CV events in Spanish patients with IRD occurred in those classified as low-to-moderate risk by SCORE2/OP, highlighting the urgent need for improved risk stratification strategies.

Carotid ultrasound for the detection of subclinical atherosclerosis (carotid plaques) has been proposed as a modifier of CV risk in the ESC 2021 guidelines. The presence of carotid plaques automatically reclassifies individuals to very high CV risk, warranting intensive lipid-lowering therapy. However, no randomized clinical trial has evaluated the efficacy of this strategy in patients with IRD.

Study Design:

PREVENER is an open-label, randomized, multicenter, phase IV clinical trial. Patients aged ≥50 years with IRD (RA by ACR/EULAR 2010 criteria, PsA by CASPAR criteria, AxSpA by ASAS criteria, or SLE by ACR/EULAR 2019 criteria) and low-to-moderate CV risk according to SCORE2/OP will be enrolled across 17 Spanish hospitals.

Eligible patients will be randomized 1:1 to:

  • Experimental group: carotid ultrasound performed within 30 days of randomization. Patients with carotid plaques (defined by Mannheim consensus criteria) will be classified as very high CV risk and initiated on high-intensity statin therapy (LDL target <55 mg/dL). Patients without plaques will be managed according to ESC 2021 guidelines.
  • Control group: standard management according to ESC 2021 guidelines throughout the study.

Randomization will be performed using REDCap, stratified by age, sex, classic CV risk factors, lipid-lowering treatment, rheumatic disease, and advanced therapy use.

Primary Endpoint:

Incidence of major adverse cardiovascular events (MACE), defined as: acute myocardial infarction or stroke, hospitalization for unstable angina, arterial revascularization for peripheral arterial disease, or CV death.

Secondary Endpoints:

  1. Efficacy of the strategy analyzed individually by rheumatic disease (RA, PsA, AxSpA)
  2. Comparison of efficacy between men and women
  3. Safety comparison of adverse events between groups

Follow-up:

All patients will be followed for 48 months. Patients on lipid-lowering treatment will have monthly visits during the intensification phase (maximum 5 visits) until therapeutic target is achieved, followed by semi-annual visits until month 48. Patients not requiring lipid-lowering treatment will have semi-annual visits throughout.

Statistical Analysis:

The primary analysis will follow an intention-to-treat approach. Cox regression models will be used to calculate Hazard Ratios with 95% confidence intervals, adjusted for relevant covariates. Kaplan-Meier survival curves will be compared using the log-rank test. A sample size of 1,944 patients provides 80% power to detect a 50% reduction in CV events in the experimental group (alpha=0.05). An interim analysis will be performed at 50% of expected events using the O'Brien-Fleming stopping rule, reviewed by an independent Data Safety Monitoring Board (DSMB).

Tipo di studio

Interventistico

Iscrizione (Stimato)

1944

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Spagna
    • Alicante
      • Alicante, Alicante, Spagna
        • Reclutamento
        • Hospital General Universitario de Alicante
        • Contatto:
      • Elche, Alicante, Spagna
      • Orihuela, Alicante, Spagna
        • Reclutamento
        • Hospital Vega Baja de Orihuela
        • Contatto:
    • Barcelona
      • Barcelona, Barcelona, Spagna
    • Cantabria
      • Laredo, Cantabria, Spagna
      • Santander, Cantabria, Spagna
        • Non ancora reclutamento
        • Hospital Universitario Marques De Valdecilla
        • Contatto:
      • Torrelavega, Cantabria, Spagna
    • Ciudad Real
      • Ciudad Real, Ciudad Real, Spagna
        • Non ancora reclutamento
        • Hospital General Universitario de Ciudad Real
        • Contatto:
    • Córdoba
      • Córdoba, Córdoba, Spagna
        • Non ancora reclutamento
        • Hospital Universitario Reina Sofia
        • Contatto:
    • Isla Baleares
      • Palma, Isla Baleares, Spagna
        • Non ancora reclutamento
        • Hospital Universitari Son Llàtzer
        • Contatto:
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spagna
        • Non ancora reclutamento
        • Hospital Universitario de Gran Canaria Dr. Negrin
        • Contatto:
    • Madrid
      • Madrid, Madrid, Spagna
      • Madrid, Madrid, Spagna
        • Non ancora reclutamento
        • Hospital Universitario Ramon y Cajal
        • Contatto:
    • Murcia
      • Murcia, Murcia, Spagna
        • Non ancora reclutamento
        • Hispital Universitario Virgen de la Arrixaca
        • Contatto:
    • Santa Cruz de Tenerife
      • San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spagna
        • Non ancora reclutamento
        • Hospital Universitario de Canarias
        • Contatto:
    • Vizcaya
      • Bilbao, Vizcaya, Spagna
        • Reclutamento
        • Hospital Universitario de Basurto
        • Contatto:
    • Álava
      • Vitoria-Gasteiz, Álava, Spagna
        • Reclutamento
        • Hospital Universitario Araba
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Experimental Group: Carotid Ultrasound
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.
Test diagnostico: Carotid Ultrasound
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
Droga: High-intensity lipid-lowering therapy
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.
Comparatore attivo: Control Group: Standard Care
Patients are managed according to standard ESC 2021 cardiovascular prevention guidelines throughout the study, without carotid ultrasound assessment.
Altro: Standard care according to ESC 2021 guidelines
Lipid-lowerin treatment indicated and managed according to ESC 2021 cardiovascular prevention guidelines, based on SCORE/OP risk stratification, without carotid ultrasound assessment

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Incidence of Major Adverse Cardiovascular Events (MACE)
Lasso di tempo: 48 months
48 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Experiencing an Acute Myocardial Infarction or Stroke
Lasso di tempo: 48 months
Incidence of acute myocardial infarction or stroke during the follow-up period.
48 months
Number of Participants Hospitalized for Unstable Angina
Lasso di tempo: 48 months
Incidence of hospital admissions due to unstable angina during the follow-up period.
48 months
Number of Participants Requiring Arterial Revascularization for Peripheral Arterial Disease
Lasso di tempo: 48 months
Incidence of arterial revascularization procedures required for peripheral arterial disease during the follow-up period.
48 months
Number of Participants Experiencing Cardiovascular Death
Lasso di tempo: 48 months
Incidence of cardiovascular death during the follow-up period.
48 months
Number of Participants Experiencing a Major Cardiovascular Event. Stratified by Rheumatic Disease Subgroup
Lasso di tempo: 48 months
Evaluation of the incidence of major cardiovascular events (acute myocardial infarction, stroke, hospitalization for unstable angina, arterial revascularization for peripheral artery disease, or cardiovascular death) analyzed individually for each included inflammatory disease (rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and systemic lupus erythematosus).
48 months
Number of Participants Experiencing a Major Cardiovascular Event. Analyzed by Sex
Lasso di tempo: 48 months
This measure evaluates the efficacy of the strategy by comparing the incidence of individual cardiovascular events (acute myocardial infarction, stroke, hospitalization for unstable angina, arterial revascularization or cardiovascular death) between male and female participants.
48 months
Incidence of adverse events
Lasso di tempo: 48 months
48 months
LDL cholesterol levels
Lasso di tempo: 48 months
48 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Instituto de Investigación Marqués de Valdecilla

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 aprile 2026

Completamento primario (Stimato)

22 aprile 2031

Completamento dello studio (Stimato)

1 dicembre 2031

Date di iscrizione allo studio

Primo inviato

14 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2026

Primo Inserito (Effettivo)

28 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PREVENER
  • 2025-521086-28-00 (Ctis)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Carotid Ultrasound

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Moldova

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi