Impact of inflammation lowering on plaques and systemic inflammatio

Phase 1

• Conditions: - Plaque characteristics- Systemic inflammation; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2022-004078-53-NL
• Lead Sponsor: Academic Medical Center (AMC), department of Internal Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-21
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- Aged 50 years and older.
- Multi-vessel coronary artery disease (defined as CAD-RADS =2 and/or PAV/NCPV stage =2).
- Serum hsCRP level =2 mg/L.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Coronary stents in situ.
- Chronic or recent (<1 month) (serious) infections and/or clinical signs of acute (serious) infection.
- History of severe auto-immune diseases, or other (severe) (recurrent or chronic) inflammatory disorders.
- Untreated latent tuberculosis, active hepatitis B (positive HBsAg and/or positive anti-HBc with detectable HBV DNA) or C, human immunodeficiency virus (HIV) not on stable antiretroviral regimen

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified