Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling

Sponsor
Ruijin Hospital
Study ID
NCT07641257
Status
Not Yet Recruiting

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Conditions

  • Acute Coronary Syndromes (ACS)
  • Atherosclerosis Cardiovascular Disease
  • Chronic Coronary Syndrome
  • Coronary Artery Disease
  • Inflammation
  • Ventricular Remodeling

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jun 11, 2026
Start date
May 30, 2026
Status verified
May 2026
Primary completion
May 30, 2028
Completion
May 30, 2029

Study Design

Enrollment
420 participants (estimated)

Arms

  • Arm: Exposure Cohort
    atients with acute or chronic coronary syndrome who are prescribed Icosapent ethyl (IPE) in addition to their standard of care (including statin therapy).
  • Arm: Control Cohort
    Patients with acute or chronic coronary syndrome receiving standard of care (including statin therapy) only, without Icosapent ethyl.

Primary Outcome Measure

Change from Baseline in Systemic Inflammatory Markers (hs-CRP, IL-6, and sST2) [ Time Frame: Baseline, 1 month, 6 months, and 12 months ]

Central Contacts

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