Acute Coronary Syndromes (ACS)NCT07641257
Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling
An observational study of Acute Coronary Syndromes (ACS) and Chronic Coronary Syndrome, run by Ruijin Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes (ACS), Chronic Coronary Syndrome, Coronary Artery Disease
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2026to 30 May 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (aged 18 years and older) diagnosed with either acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) who present to the cardiology inpatient wards or outpatient clinics of the participating medical centers. These are real-world patients who have elevated fasting triglyceride levels (>= 1.7 mmol/L) and are routinely receiving standard-of-care cardiovascular therapies, including statin therapy. Depending on their routine clinical prescriptions determined by their treating physicians, they are either receiving Icosapent ethyl (IPE) as an add-on therapy or continuing with standard of care alone.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease, Ventricular Remodeling, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). | |
| Control Cohort | Patients with acute or chronic coronary syndrome receiving standard of care (including statin therapy) only, without Icosapent ethyl. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Systemic Inflammatory Markers (hs-CRP, IL-6, and sST2)
Evaluate the relative and absolute changes in systemic inflammation and cardiac stress markers, including high-sensitivity C-reactive protein (hs-CRP), Interleukin-6 (IL-6), and soluble suppression of tumorigenicity 2 (sST2).
Measured: Baseline, 1 month, 6 months, and 12 months
Change from Baseline in Vulnerable Plaque Markers (Lp-PLA2 and UACR)
Evaluate the changes in cardiovascular and microvascular vulnerability markers, specifically Lipoprotein-associated phospholipase A2 (Lp-PLA2) and Urinary albumin-to-creatinine ratio (UACR).
Measured: Baseline, 1 month, 6 months, and 12 months
Change from Baseline in Lipid Profile Parameters
Assess changes in lipid metabolism parameters, including triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), Apolipoprotein A1 (ApoA1), Apolipoprotein B (ApoB), and Lipoprotein(a) [Lp(a)].
Measured: Baseline, 1 month, 6 months, and 12 months
Secondary outcomes (11)
Change from Baseline in Echocardiographic Parameters of Ventricular Remodeling
Evaluate structural and functional changes of the left ventricle by calculating Left Ventricular End-Diastolic Volume (LVEDV) and Left Ventricular End-Systolic Volume (LVESV) via transthoracic echocardiography.
Measured: Baseline, 1 month, 6 months, and 12 months
Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Evaluate changes in the myocardial wall stress and heart failure biomarker NT-proBNP.
Measured: Baseline, 1 month, 6 months, and 12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Change in Coronary Plaque Maximum Thickness Evaluated by CTA (Unit: mm)
Measured: Baseline and 9 or 12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Change in Coronary Plaque Length Evaluated by CTA (Unit: mm)
Measured: Baseline and 9/12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Change in Coronary Plaque Area Evaluated by CTA (Unit: mm^2)
Measured: Baseline and 9/12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Change in Degree of Coronary Luminal Stenosis Evaluated by CTA (Unit: percentage)
Measured: Baseline and 9/12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Change in Proportion of Hypoechoic Plaque Components Evaluated by CTA (Unit: percentage)
Measured: Baseline and 9/12 months
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Evaluate changes in Fasting Blood Glucose (FBG) among participants with a history of diabetes.
Measured: Baseline, 1 month, 6 months, and 12 months
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Evaluate changes in Insulin (INS) among participants with a history of diabetes.
Measured: Baseline, 1 month, 6 months, and 12 months
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Evaluate changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) among participants with a history of diabetes.
Measured: Baseline, 1 month, 6 months, and 12 months
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Evaluate changes in Hemoglobin A1c (HbA1c) among participants with a history of diabetes.
Measured: Baseline, 1 month, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start30 May 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641257
- Sponsor's protocol ID
- 2026-358
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) that underlie the results reported in the primary publication, along with the study protocol and statistical analysis plan, will be shared. Data will be available upon reasonable request to the Principal Investigator, beginning 6 months and ending 36 months following article publication. To gain access, researchers must submit a methodologically sound proposal for secondary analysis or meta-analysis. The proposal will be reviewed by the study steering committee. If approved, data sharing will be strictly subject to a formal data-sharing agreement and must comply with the ethical regulations of the participating institutions. No specific IPD will be shared unconditionally.
Publications
Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. doi: 10.1056/NEJMoa1812792. Epub 2018 Nov 10.
PubMed 30415628
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07641257
- Acronym / sponsor ID
- 2026-358
- Conditions
- Acute Coronary Syndromes (ACS), Chronic Coronary Syndrome, Coronary Artery Disease, Atherosclerosis Cardiovascular Disease, Ventricular Remodeling, Inflammation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
| Control Cohort | – | –Patients with acute or chronic coronary syndrome receiving standard of care (including statin therapy) only, without Icosapent ethyl. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18 years and older) diagnosed with either acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) who present to the cardiology inpatient wards or outpatient clinics of the participating medical centers. These are real-world patients who have elevated fasting triglyceride levels (>= 1.7 mmol/L) and are routinely receiving standard-of-care cardiovascular therapies, including statin therapy. Depending on their routine clinical prescriptions determined by their treating physicians, they are either receiving Icosapent ethyl (IPE) as an add-on therapy or continuing with standard of care alone.
Key inclusion criteria (4 listed)
- Age 18 years and older, of any sex.
Key exclusion criteria (5 listed)
- Women who are planning a pregnancy, currently pregnant, or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in Systemic Inflammatory Markers (hs-CRP, IL-6, and sST2)
Time frame: Baseline, 1 month, 6 months, and 12 months
Evaluate the relative and absolute changes in systemic inflammation and cardiac stress markers, including high-sensitivity C-reactive protein (hs-CRP), Interleukin-6 (IL-6), and soluble suppression of tumorigenicity 2 (sST2).
Change from Baseline in Vulnerable Plaque Markers (Lp-PLA2 and UACR)
Time frame: Baseline, 1 month, 6 months, and 12 months
Evaluate the changes in cardiovascular and microvascular vulnerability markers, specifically Lipoprotein-associated phospholipase A2 (Lp-PLA2) and Urinary albumin-to-creatinine ratio (UACR).
Change from Baseline in Lipid Profile Parameters
Time frame: Baseline, 1 month, 6 months, and 12 months
Assess changes in lipid metabolism parameters, including triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), Apolipoprotein A1 (ApoA1), Apolipoprotein B (ApoB), and Lipoprotein(a) [Lp(a)].
11 secondary outcomes
Change from Baseline in Echocardiographic Parameters of Ventricular Remodeling
Time frame: Baseline, 1 month, 6 months, and 12 months
Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: Baseline, 1 month, 6 months, and 12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Time frame: Baseline and 9 or 12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Time frame: Baseline and 9/12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Time frame: Baseline and 9/12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Time frame: Baseline and 9/12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Time frame: Baseline and 9/12 months
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Time frame: Baseline, 1 month, 6 months, and 12 months
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Time frame: Baseline, 1 month, 6 months, and 12 months
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Time frame: Baseline, 1 month, 6 months, and 12 months
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Time frame: Baseline, 1 month, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Results publication: PubMed 30415628Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. doi: 10.1056/NEJMoa1812792. Epub 2018 Nov 10.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) that underlie the results reported in the primary publication, along with the study protocol and statistical analysis plan, will be shared. Data will be available upon reasonable request to the Principal Investigator, beginning 6 months and ending 36 months following article publication. To gain access, researchers must submit a methodologically sound proposal for secondary analysis or meta-analysis. The proposal will be reviewed by the study steering committee. If approved, data sharing will be strictly subject to a formal data-sharing agreement and must comply with the ethical regulations of the participating institutions. No specific IPD will be shared unconditionally.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes (ACS) and Chronic Coronary Syndrome, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueying Wang (+86 18202513787, wangyueying9228@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07641257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.