Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT04562467
Eligibility Criteria:
Inclusion Criteria:
1. Women ≥65 years of age and men ≥40 years of age with established CVD (see criterion 'a' below) or ≥50 years of age with diabetes and one additional CV risk factor (see criterion 'b' below)
1. Those with established CVD should have ≥1 of the following clinical history
* Documented coronary artery disease (CAD)
* Prior MI
* Multivessel CAD (≥50% stenosis in ≥2 major epicardial coronary arteries)
* Hospitalization for high-risk non-ST-segment elevation acute coronary syndrome
* Documented cerebrovascular or carotid disease (≥1 of the following)
* Prior ischemic stroke
* Carotid artery disease with ≥50% stenosis
* History of carotid revascularization
* Documented peripheral artery disease (≥1 of the following)
* Ankle-brachial index (ABI) \<0.9 with symptoms of intermittent claudication
* History of aorto-iliac or peripheral arterial intervention
2. Those with a history of diabetes (either type 1 or type 2 diabetes mellitus) but no CVD should also have ≥1 of the following:
* Cigarette smoker or stopped smoking within 3 months before the baseline visit
* Documented hypertension OR on antihypertensive agents
* HDL-C ≤1.0 mmol/L for men or ≤1.3 mmol/L for women
* High sensitivity C-reactive protein \>3.0 mg/L
* eGFR 30 to 60 mL/min/1.73m2
* Documented micro- or macro-albuminuria
* Retinopathy
* Non-proliferative retinopathy
* Preproliferative or proliferative retinopathy
* Maculopathy
* Advanced diabetic retinopathy
* History of photocoagulation
* ABI \<0.9 without symptoms of intermittent claudication
2. Elevated triglycerides (≥1.5 mmol/L but \<5.6 mmol/L)
3. On stable statin therapy for ≥4 weeks at the baseline visit
4. Willing to provide written informed consent and be compliant with the study requirements
5. Willing and able to follow the diet recommended by the study doctor
Exclusion Criteria:
1. Participation in another clinical trial with an investigational agent ≤90 days prior to screening
2. Women who are of childbearing potential
3. Any condition or therapy which the study doctor thinks might pose a risk to the participant
4. Severe (New York Heart Association class IV) heart failure
5. Any life-threatening disease expected to result in death within the next 2 years
6. Diagnosis or laboratory evidence of active severe liver disease
7. HbA1c \>10.0% at the baseline visit
8. SBP ≥200 mmHg or DBP ≥100 mmHg (despite being on antihypertensive therapy)
9. Planned coronary intervention or any non-cardiac major surgical procedure
10. Known familial lipoprotein lipase deficiency, apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia
11. Statin intolerant or hypersensitivity to statin therapy
12. Require peritoneal dialysis or hemodialysis
13. eGFR \<30 mL/min/1.73m2
14. History of atrial fibrillation
15. History of major bleeding event(s)
16. Documented history of pancreatitis
17. Malabsorption syndrome and/or chronic diarrhea
18. Known acquired immunodeficiency syndrome
19. Unexplained elevated creatine kinase concentration \>5 × the upper limits of normal or elevation due to known muscle disease
20. Use of niacin, fibrates, omega-3 fatty acids, dietary supplements containing omega-3 fatty acids, bile acid sequestrants or PCSK9 inhibitors
21. Known hypersensitivity to fish and/or shellfish, or ingredients of IPE
22. Inability to swallow IPE capsules whole
23. Drug or alcohol abuse within the past 6 months, and inability/unwillingness to abstain from drug abuse and excessive alcohol consumption during the study
24. Mental/psychological concerns or any other reason to expect difficulty in complying with the study requirements or understanding the goal and potential risks of being a part of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04562467
Study Brief:
Protocol Section:
NCT04562467