Comparing treatments for reducing vascular inflammation in coronary artery disease

Vascular Inflammation ReDuction and Perivascular Fat Imaging by Computed Tomography

This study is testing if a stronger treatment with atorvastatin and colchicine can help reduce inflammation in the blood vessels of people with coronary artery disease better than standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 30 Years to 80 Years
• Sex: All
• Sponsor: Hippocration General Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Athens, Attica)
• Trial ID: NCT06083337 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of intensified treatment using atorvastatin and colchicine compared to standard care in reducing vascular inflammation in patients with coronary artery disease. Participants aged 30-80 with mild coronary artery plaques will be randomized into two groups: one receiving standard care and the other receiving the intensified treatment. The study will monitor participants over a 6-month period, assessing changes in vascular inflammation through imaging and blood biomarker analysis. The goal is to determine if the intensified treatment leads to greater reductions in inflammation as measured by fat attenuation index scores from coronary computed tomography angiography.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 30 to 80 with mild coronary artery plaques and elevated fat attenuation index scores.

Not a fit: Patients with a history of significant coronary artery disease requiring treatment, such as myocardial infarction or revascularization, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment strategy for reducing vascular inflammation in patients with coronary artery disease.

How similar studies have performed: Other studies have shown promise in using similar approaches to reduce vascular inflammation, but this specific methodology is novel.

Eligibility criteria

Inclusion Criteria:

Participants must satisfy the following conditions:

1. Male or female, aged 30 to 80 years
2. CCTA scan showing mild coronary artery plaques (\<50% luminal stenosis) and CaRi-Heart Risk ≥ 5% and/or FAI-Score ≥ 75th percentile in the left anterior coronary or right coronary artery or FAI-Score ≥ 95th percentile in the circumflex coronary within the last 6 months.
3. Willing and able (in the Investigators opinion) to comply with all study requirements.
4. Able to understand both verbal or written Greek
5. No definite clinical indication for a change in treatment based on European Society of Cardiology guidelines or planned revascularization

Exclusion Criteria:

The participant may not enter the study if ANY of the following are known to apply:

1. Previous documented history of coronary artery disease requiring treatment. This includes any of the following:

   i. Acute myocardial infarction ii. Unstable angina iii. Coronary revascularization procedure iv. Clinically significant coronary artery disease diagnosed by invasive or non-invasive testing.
2. History of New York Heart Association (NYHA) Class III or IV heart failure within the past 12 months of consent.
3. Autoimmune disease requiring immunosuppressive therapy or systemic corticosteroid therapy
4. Active chronic treatment with any anti-inflammatory agents (e.g. NSAIDs, systemic corticosteroids)
5. Active neoplasm requiring surgery, chemotherapy, or radiation within the prior 12 months (subjects with a history of malignancy who have undergone curative resection or otherwise not requiring treatment for at least 12 months prior to screening with no detectable recurrence are allowed)
6. Contraindication for statin therapy. Patients with intolerance to colchicine therapy may be included but they will receive statin treatment only.
7. Severe Chronic kidney disease (estimated glomerular filtration rate \< 30 mL/min/1.73 m² and/or serum creatinine \> 2.5 mg/dL or 220 µmol/l).
8. Hepatic dysfunction (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \> 3 × the upper limit of normal \[ULN\] measured on local labs in last 6 months)
9. Any clinically significant abnormality identified at the time of screening that, in the opinion of the Investigator, would preclude safe completion of the study.
10. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
11. Participants who have participated in another research study involving a treatment intervention or an investigational product, in the past 12 weeks.
12. Patients unable to understand verbal or written English.
13. Contraindication to contract dye for CCTA.
14. Pregnancy

Where this trial is running

Athens, Attica

• 1st Cardiology Department, Hippokration General Hospital of Athens — Athens, Attica, Greece (Recruiting)

Study contacts

• Principal investigator: Alexios S Antonopoulos, MD, PhD — 1st Cardiology Department, Hippokration General Hospital of Athens
• Study coordinator: Alexios S Antonopoulos, MD, PhD

Conditions Coronary Artery Disease; Atheroscleroses, Coronary; Vascular Inflammation; vascular inflammation; fat attenuation index; pericoronary adipose tissue; coronary computed tomography angiography