NCT07641257Not yet recruiting
Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling
Impact of Icosapent Ethyl on Ventricular Remodeling, Inflammation, and Coronary Plaque Stability in Patients With Acute or Chronic Coronary Syndrome: A Prospective, Observational, Real-World Study
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 420 (estimated)
- First submitted
- 25 May 2026
- Start date
- 30 May 2026
- Primary completion date
- 30 May 2028
- Lead sponsor
- Ruijin Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07641257
What you commit to
- Study type: Observational
- Planned participants: 420
- From 30 May 2026 to the primary completion date, 30 May 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women who are planning a pregnancy, currently pregnant, or lactating.
- Known hypersensitivity or allergic reaction to the active ingredient of icosapent ethyl (IPE) or any of its excipients (applicable to patients in the exposure cohort).
- Diagnosed with major life-threatening conditions such as malignant tumors, end-stage lung disease, or advanced neurodegenerative diseases, with a life expectancy of less than 12 months.
- Concurrent participation in any other interventional clinical trial involving investigational drugs or medical devices.
- Any other condition or severe non-compliance that, in the judgment of the investigator, makes the patient unsuitable for enrollment in this study.
Who the study is looking for
- Age 18 years and older, of any sex.
- Definite diagnosis of chronic coronary syndrome (CCS) according to the Chinese Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndrome, or acute coronary syndrome (ACS) according to the 2025 ACC/AHA/ACEP/NAEMSP/SACI Guideline for the Management of Acute Coronary Syndromes.
- Laboratory evaluation showing fasting triglycerides (TG) \>= 1.7 mmol/L.
- Ability to fully understand the study purpose, voluntary participation, and provision of signed written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.