BEMPEDOIC ACID for Rheumatoid arthritis|Psoriatic arthritis|Axial spondyloarthritis|Systemic lupus erythematosus

Inclusion criteria

• {"criterion_text":"- Patients who have given written informed consent."}
• {"criterion_text":"- Patients ≥50 years of age"}
• {"criterion_text":"- Patients meeting classification criteria for any of the following rheumatic CIS: rheumatoid arthritis (RA, ACR/EULAR criteria) or psoriatic arthritis (PsA, CASPAR criteria) or axial spondyloarthritis (EspAax, ASAS criteria) or systemic lupus erythematosus (SLE, ACR/EULAR criteria) (annex IV)"}
• {"criterion_text":"- Patients included in the low-moderate CV risk groups according to SCORE2/OP (Annex V)"}

Exclusion criteria

• {"criterion_text":"- Presence of CV events, type 2 DM, familial hypercholesterolemia or chronic kidney disease that imply classification in the high/very high CV risk groups."}
• {"criterion_text":"- Patients who, either in the context of research studies or as a result of decisions made in routine clinical practice, and meeting the previously mentioned inclusion criteria, have undergone carotid ultrasound and therapeutic intervention as a consequence."}
• {"criterion_text":"- Patients with contraindications to lipid-lowering therapies, including a history of recent alcoholism and the presence of active liver disease or with unwarranted and persistent elevations of serum transaminases exceeding three times the maximum normal value (for statins and ezetimibe)."}

Primary endpoints

• {"endpoint_text":"- occurrence of a major cardiovascular event: acute myocardial infarction or stroke, hospital admission for unstable angina, arterial revascularization for peripheral artery disease, death due to CV disease","definition_or_measurement_approach":"Occurrence of the specified events (acute myocardial infarction, stroke, hospital admission for unstable angina, arterial revascularization for peripheral artery disease, or death due to CV disease)."}

Secondary endpoints

• {"endpoint_text":"- individualized appearance of each of the cardiovascular events that make up the primary endpoint","definition_or_measurement_approach":"Occurrence of each individual cardiovascular event composing the primary composite endpoint (as specified for the primary endpoint)."}

Spain

Earliest CTIS Part Ii Submission Date

08-09-2025

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

155

Number Of Sites

15

Number Of Participants

1250

Primary sponsor

Full Name

Instituto De Investigacion Marques De Valdecilla

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain