Recruiting

Study of cardiovascular disease prevention using carotid ultrasound in patients with inflammatory rheumatic diseases treated with amlodipine, atorvastatin, rosuvastatin, ezetimibe and bempedoic acid

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on preventing cardiovascular disease in people who have chronic inflammatory rheumatic diseases such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, or systemic lupus erythematosus. The study aims to evaluate whether using carotid ultrasound helps identify and treat patients who may be at high risk for heart and blood vessel problems.

The study uses several medications to help lower cholesterol and protect the heart, including combinations of amlodipine and atorvastatin, as well as rosuvastatin with ezetimibe. Another medication being tested is bempedoic acid. These medications are taken by mouth daily over a period of up to 48 months.

The researchers will monitor participants to see if they develop any serious heart or blood vessel problems, such as heart attacks, strokes, or other complications that require hospital treatment. This will help determine if using ultrasound scanning to guide treatment decisions leads to better outcomes compared to current standard treatment approaches.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your participation begins with a medical assessment to confirm you have one of these conditions: rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, or systemic lupus erythematosus
A cardiovascular risk assessment will be performed using the SCORE2/OP evaluation system
Step 2
Treatment assignment
You will be assigned to receive one of the following oral medications:
- Atorvastatin combined with amlodipine
- Rosuvastatin combined with ezetimibe
- Bempedoic acid
Step 3
Treatment period
The treatment period will continue from your start date until December 2029
During this time, you will be monitored for any cardiovascular events such as:
- Heart attack (acute myocardial infarction)
- Stroke
- Hospital admission for chest pain (unstable angina)
- Blood vessel procedures (arterial revascularization)
Regular medical check-ups will be conducted to monitor your health status
Step 4
Final evaluation
The study concludes with a final medical assessment
Your participation ends in December 2029

Who can join the trial?

8 criteria

You must be at least 50 years old
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You must have been diagnosed with one of these inflammatory rheumatic conditions:
- Rheumatoid arthritis (RA) - a condition that causes joint inflammation
- Psoriatic arthritis (PsA) - joint inflammation related to psoriasis
- Axial spondyloarthritis - inflammation affecting mainly the spine
- Systemic lupus erythematosus (SLE) - an autoimmune disease affecting multiple organs
- You must be classified in the low to moderate cardiovascular risk groups according to SCORE2/OP evaluation system (a method doctors use to assess heart and blood vessel disease risk)
- You must be willing and able to provide written informed consent (formal agreement to participate in the study)
- Both men and women can participate in this study

Who cannot join the trial?

15 criteria

History of cardiovascular events (such as heart attack or stroke)
Already diagnosed with high blood pressure or currently taking blood pressure medications
Known diabetes or currently taking diabetes medications
Previous diagnosis of high cholesterol or currently taking cholesterol-lowering medications
Pregnancy or planning to become pregnant during the study period
Current participation in other clinical trials
Unable to provide informed consent
Severe kidney or liver problems
Active cancer or ongoing cancer treatment
History of blood clotting disorders
Severe mental health conditions that could affect participation
Substance abuse within the past year
Unable to attend regular follow-up visits
Known allergies to medications commonly used in cardiovascular prevention
Life expectancy less than 12 months due to other medical conditions

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
El Hospital Universitario De Gran Canaria Dr. Negrin
Las Palmas De Gran Canaria, Spain
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Universitario Araba
Vitoria, Spain

Trial locations

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Investigated drugs

Based on the provided trial data, this appears to be an observational study focused on ultrasound imaging rather than testing specific medications. The primary intervention is: Carotid Ultrasound - This is a non-invasive imaging technique that uses sound waves to create pictures of the carotid arteries in the neck. It helps doctors see if there is any narrowing or blockage in these blood vessels that could increase the risk of cardiovascular disease. This test is used to identify patients with rheumatic diseases who might be at higher risk of heart problems, even if traditional risk calculations show them at low or moderate risk. Note: The trial description does not specify any medications being tested, as it appears to be comparing different strategies for identifying cardiovascular risk in patients with inflammatory rheumatic diseases.

What is already known about the treatment

Since no specific medications are listed in the provided trial data, I cannot create medication descriptions in the requested format. The trial appears to be a study about cardiovascular disease prevention strategy using carotid ultrasound in patients with inflammatory rheumatic diseases, but it doesn't mention any specific medications being tested. If you'd like medication descriptions, please provide the names of the specific medications involved in the trial, and I will create descriptions following your requested format: Medication Name – description in a single paragraph.

Investigated diseases

Rheumatoid Arthritis
A chronic inflammatory condition that primarily affects joints, causing swelling, pain, and stiffness. The disease typically starts in smaller joints of hands and feet, progressing symmetrically to larger joints. Over time, it can lead to joint deformity and reduced mobility.
Psoriatic Arthritis
A form of arthritis that develops in some people with psoriasis, causing joint pain, stiffness, and swelling. It can affect any joint in the body and may also cause changes in the nails and fatigue. The condition can vary from mild to severe, and symptoms may come and go.
Axial Spondyloarthritis
A chronic inflammatory arthritis primarily affecting the spine and sacroiliac joints. The condition typically causes back pain and stiffness, particularly in the morning or after periods of inactivity. It can also affect other joints and may cause fatigue.
Systemic Lupus Erythematosus
A complex autoimmune disease that can affect multiple organs and body systems. The condition commonly causes joint pain, skin rashes, and fatigue. Symptoms typically come and go in periods of flares and remissions, varying in intensity and combination.