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

2026年11月5日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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).

研究类型

介入性

注册 (估计的)

1944

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 西班牙
    • Alicante
      • Alicante、Alicante、西班牙
      • Elche、Alicante、西班牙
      • Orihuela、Alicante、西班牙
        • 招聘中
        • Hospital Vega Baja de Orihuela
        • 接触：
    • Barcelona
      • Barcelona、Barcelona、西班牙
    • Cantabria
      • Laredo、Cantabria、西班牙
      • Santander、Cantabria、西班牙
        • 尚未招聘
        • Hospital Universitario Marqués de Valdecilla
        • 接触：
      • Torrelavega、Cantabria、西班牙
    • Ciudad Real
      • Ciudad Real、Ciudad Real、西班牙
    • Córdoba
      • Córdoba、Córdoba、西班牙
        • 尚未招聘
        • Hospital Universitario Reina Sofía
        • 接触：
    • Isla Baleares
      • Palma、Isla Baleares、西班牙
        • 尚未招聘
        • Hospital Universitari Son LLàtzer
        • 接触：
    • Las Palmas
      • Las Palmas de Gran Canaria、Las Palmas、西班牙
        • 尚未招聘
        • Hospital Universitario de Gran Canaria Dr. Negrín
        • 接触：
    • Madrid
      • Madrid、Madrid、西班牙
      • Madrid、Madrid、西班牙
        • 尚未招聘
        • Hospital Universitario Ramón y Cajal
        • 接触：
    • Murcia
      • Murcia、Murcia、西班牙
        • 尚未招聘
        • Hispital Universitario Virgen de la Arrixaca
        • 接触：
    • Santa Cruz de Tenerife
      • San Cristóbal de La Laguna、Santa Cruz de Tenerife、西班牙
    • Vizcaya
      • Bilbao、Vizcaya、西班牙
        • 招聘中
        • Hospital Universitario de Basurto
        • 接触：
    • Álava
      • Vitoria-Gasteiz、Álava、西班牙
        • 招聘中
        • Hospital Universitario Araba
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
诊断测试：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

药品：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.
有源比较器：Control Group: Standard Care

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

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Incidence of Major Adverse Cardiovascular Events (MACE)
大体时间：48 months
48 months

次要结果测量

结果测量
措施说明
大体时间
Incidence of adverse events
大体时间：48 months
48 months
LDL cholesterol levels
大体时间：48 months
48 months
Number of Participants Experiencing an Acute Myocardial Infarction or Stroke
大体时间：48 months

Incidence of acute myocardial infarction or stroke during the follow-up period.
48 months
Number of Participants Hospitalized for Unstable Angina
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Instituto de Investigación Marqués de Valdecilla

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月22日

初级完成 (估计的)

2031年4月22日

研究完成 (估计的)

2031年12月1日

研究注册日期

首次提交

2026年5月14日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月28日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PREVENER
  • 2025-521086-28-00 (克蒂斯)
  • 2025 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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