Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling (NCT07641257) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling
420 participantsStarted 2026-05-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying icosapent ethyl in people with conditions like acute coronary syndrome and coronary artery disease — given my specific diagnosis, is this the kind of trial that might be worth revisiting once it opens for enrollment?
2The trial is measuring changes in inflammatory markers like hs-CRP and IL-6, as well as plaque and lipid markers — do you currently track any of these in my care, and what do my numbers look like right now?
3Since this trial is listed as 'not yet recruiting,' is there a standard treatment path I should be on in the meantime, and would starting that now affect whether I could participate later?
4The trial phase is listed as 'NA,' which means the traditional phase framework may not apply here — can you help me understand what that means for how much is already known about the safety and effectiveness of icosapent ethyl in someone with my condition?
5This study looks at ventricular remodeling as one of its focus areas — is that something that's relevant to my situation, and should I be monitoring for it regardless of whether I join this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Systemic Inflammatory Markers (hs-CRP, IL-6, and sST2)
Timeframe: Baseline, 1 month, 6 months, and 12 months
2
Change from Baseline in Vulnerable Plaque Markers (Lp-PLA2 and UACR)
Timeframe: Baseline, 1 month, 6 months, and 12 months
3
Change from Baseline in Lipid Profile Parameters
Timeframe: Baseline, 1 month, 6 months, and 12 months