The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk (IPE-PREVENTION)
Cardiovascular Diseases, Cardiovascular Risk Factor, Triglycerides High
About this trial
This is an interventional basic science trial for Cardiovascular Diseases focused on measuring Cardiometabolic Risk, Type 2 Diabetes, Icosapent Ethyl, Omega-3, Vascular Diseases, Progenitor Cells, Vascular Disease, Blood Lipids
Eligibility Criteria
Inclusion Criteria:
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)
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
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
- Elevated triglycerides (≥1.5 mmol/L but <5.6 mmol/L)
- On stable statin therapy for ≥4 weeks at the baseline visit
- Willing to provide written informed consent and be compliant with the study requirements
- Willing and able to follow the diet recommended by the study doctor
Exclusion Criteria:
- Participation in another clinical trial with an investigational agent ≤90 days prior to screening
- Women who are of childbearing potential
- Any condition or therapy which the study doctor thinks might pose a risk to the participant
- Severe (New York Heart Association class IV) heart failure
- Any life-threatening disease expected to result in death within the next 2 years
- Diagnosis or laboratory evidence of active severe liver disease
- HbA1c >10.0% at the baseline visit
- SBP ≥200 mmHg or DBP ≥100 mmHg (despite being on antihypertensive therapy)
- Planned coronary intervention or any non-cardiac major surgical procedure
- Known familial lipoprotein lipase deficiency, apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia
- Statin intolerant or hypersensitivity to statin therapy
- Require peritoneal dialysis or hemodialysis
- eGFR <30 mL/min/1.73m2
- History of atrial fibrillation
- History of major bleeding event(s)
- Documented history of pancreatitis
- Malabsorption syndrome and/or chronic diarrhea
- Known acquired immunodeficiency syndrome
- Unexplained elevated creatine kinase concentration >5 × the upper limits of normal or elevation due to known muscle disease
- Use of niacin, fibrates, omega-3 fatty acids, dietary supplements containing omega-3 fatty acids, bile acid sequestrants or PCSK9 inhibitors
- Known hypersensitivity to fish and/or shellfish, or ingredients of IPE
- Inability to swallow IPE capsules whole
- Drug or alcohol abuse within the past 6 months, and inability/unwillingness to abstain from drug abuse and excessive alcohol consumption during the study
- 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
Sites / Locations
- The Oshawa Clinic
- Diagnostic Assessment Centre
- Langstaff Medical Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Icosapent Ethyl + Standard of Care
Standard of Care
Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] 2 x 1g capsules BID (4g total) as per REDUCE-IT
Standard of care therapy (including statin therapy as per inclusion criteria)