Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling
NCT07641257 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 420
Last updated 2026-06-11
Summary
Even with standard treatments like statins, patients with coronary artery disease often face a residual risk of further heart events. This risk is largely driven by ongoing inflammation and unstable fatty plaques in the heart's blood vessels. Icosapent ethyl (IPE) is a highly purified prescription medication known to improve cardiovascular outcomes, but its detailed effects on the heart's structure and inflammation in everyday clinical practice need further exploration.
This study is a prospective, observational, real-world study designed to evaluate the effectiveness of IPE in patients with Acute Coronary Syndrome (ACS) or Chronic Coronary Syndrome (CCS). The study plans to enroll 420 patients who will be followed for 12 months. Based on their routine clinical prescriptions, participants will be grouped into a control group (receiving standard cardiovascular care, including statins) and an exposure group (receiving standard care plus IPE).
Throughout the 1-year follow-up, researchers will conduct regular blood tests and advanced heart imaging. The main goal is to determine if adding IPE to standard therapy leads to a more significant reduction in inflammation. Additionally, the study will observe how IPE affects the stability of coronary plaques and the healing process of ventricular remodeling in a real-world clinical setting.
Conditions
- Acute Coronary Syndromes (ACS)
- Chronic Coronary Syndrome
- Coronary Artery Disease
- Atherosclerosis Cardiovascular Disease
- Ventricular Remodeling
- Inflammation
Sponsors & Collaborators
-
Ruijin Hospital
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-30
- Primary Completion
- 2028-05-30
- Completion
- 2029-05-30
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