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Prevention study for Rheumatoid Arthritis (RA)
Official title Carotid Ultrasound-Based Strategy for Primary Prevention of Cardiovascular Events in Inflammatory Rheumatic Disease (PREVENER)
ClinicalTrials.gov ID: NCT07611747
What this study is testing
What is High-intensity lipid-lowering therapy?
High-intensity lipid-lowering therapy is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for rheumatoid arthritis (ra).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 48 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join 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
You likely can't join if
- Presence of previous cardiovascular events, type 2 diabetes mellitus, familial hypercholesterolemia, or chronic kidney disease resulting in...
- Prior carotid ultrasound examination with subsequent therapeutic intervention derived from its results, either in the context of a research study or...
- Contraindications to lipid-lowering therapy, including recent history of alcoholism, active liver disease, or unexplained and persistent elevation of...
See the full eligibility criteria
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- 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
- Murcia, Murcia, Spain
- San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
- Bilbao, Vizcaya, Spain
- Vitoria-Gasteiz, Álava, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 48 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alicante, Alicante, Spain; Elche, Alicante, Spain; Orihuela, Alicante, Spain; Barcelona, Barcelona, Spain; Laredo, Cantabria, Spain; Santander, Cantabria, Spain and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.