Cardiovascular DiseasesPhase 4IPE-PREVENTIONNCT04562467
The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk
A Phase 4 study testing Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by Canadian Medical and Surgical Knowledge Translation Research Group at 3 sites in Canada.
Trial summary
IPE-PREVENTION is a prospective, randomized, 3-month long, open-label study. A total of 70 individuals with elevated cardio-metabolic risk and heightened triglyceride levels, and who are on stable statin therapy will be randomized (1:1) to receive either icosapent ethyl (IPE) 2g BID or standard of care. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor, Triglycerides High
- What is being tested?
- Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesCanada
- Study dates
- 24 Sep 2020to 25 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 31Show fewer
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
The Oshawa Clinic
Oshawa, Ontario, L1H 1B9
Diagnostic Assessment Centre
Scarborough Village, Ontario, M1S4N6
Langstaff Medical Clinic
Vaughan, Ontario, L4L 0K8
About this study
Official title: The Icosapent Ethyl and Prevention of Vascular Regenerative Cell Exhaustion Study
IPE-PREVENTION is a prospective, randomized, 3-month long, open-label study. A total of 70 individuals with elevated cardio-metabolic risk and heightened triglyceride levels, and who are on stable statin therapy will be randomized (1:1) to receive either icosapent ethyl (IPE) 2g BID or standard of care.
It is hypothesized that assignment to IPE will lower progenitor cell depletion as well as limit progenitor cell dysfunction. This study may offer some molecular and cellular insights into the mechanisms underlying the cardiovascular benefits of IPE therapy reported in the REDUCE-IT trial.
Read the detailed description
The development and natural history of atherothrombosis involves the pathophysiological interplay between inflammation, dyslipidemia, oxidative stress and endothelial dysfunction. Unregulated, these processes culminate in endothelial dysfunction, and ultimately cardio-metabolic chronic diseases. Aberrant lipid oxidation due to elevated triglycerides and cholesterol primes and activates innate immune cell activity resulting in elevated inflammation and oxidative stress.
The randomized, placebo-controlled REDUCE-IT trial enrolled individuals with established atherosclerotic heart disease, or diabetes and an additional risk factor, who were on pre-existing statin therapy with persistent hypertriglyceridemia. REDUCE-IT reported that the group allocated to the omega-3 fatty acid icosapent ethyl (IPE; 2g BID) exhibited a 25% relative risk reduction for the primary composite endpoint of CV death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina, and a 20% decreased risk of CV death when compared to standard of care. Vascepa® (IPE) is currently approved by Health Canada and the U.S. FDA for the reduction of cardiovascular risk in statin-treated individuals with elevated triglycerides who are either at heightened cardiovascular risk or who have diabetes and at least one risk factor.
The exact mechanism through which IPE decreased cardiovascular events in REDUCE-IT has not yet been elucidated.
The population and function of circulating pro-vascular progenitor cells have been shown to benefit from diminished lipid oxidation, inflammation and oxidative stress. A healthy population of circulating pro-vascular progenitor cells in turn affords timely and efficient blood vessel repair, regeneration and atheroprotection.
The omega-3 fatty acid eicosapentaenoic acid (EPA) has been reported to inhibit M1 macrophage polarization in a murine model and increase human endothelial progenitor cell (EPC) colony formation and functionality in vitro. In vivo, EPA levels have been observed to correlate significantly with circulating EPC number (CD34+CD133+VEGFR2+ cells). Collectively, these findings affirm that EPA, and potentially omega-3 fatty acids, can enhance the number and function of circulating pro-vascular progenitor cells and can alter M1/M2 macrophage balance towards a regenerative blood vessel phenotype.
IPE-PREVENTION is a prospective, 3-month long, open-label study that will randomize a total of 70 individuals with elevated cardio-metabolic risk and heightened triglyceride levels and who are on stable statin therapy to either IPE 2g BID or standard of care. Blood samples will be collected at the baseline and month 3 visits for evaluations of cell populations in the blood as well as measurements of biomarkers that contribute to the proinflammatory and pro-oxidant milieu of individuals at elevated cardio-metabolic risk. The study will utilize the AldefluorTM assay to differentiate between and enumerate hematopoietic progenitor cells, EPCs, granulocyte precursors and macrophage precursors. The overarching goal would be to document how assignment to IPE and standard-of-care impact on circulating progenitor cell depletion and dysfunction. The effect of IPE exposure on the inflammatory and oxidative profile will also be assessed.
The results of this investigation may offer some molecular and cellular insights into the mechanisms underlying the cardiovascular benefits of IPE therapy reported in the REDUCE-IT trial.
- Conditions
- Cardiovascular Diseases, Cardiovascular Risk Factor, Triglycerides High, Diabetes Mellitus, Type 2
- Being tested
- Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]
- Keywords
- Cardiometabolic Risk, Type 2 Diabetes, Icosapent Ethyl, Omega-3, Vascular Diseases, Progenitor Cells, Vascular Disease, Blood Lipids
- Medical subject headings
- Cardiovascular Diseases, Hypertriglyceridemia, Diabetes Mellitus, Type 2, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]Drug
Also called Vascepa, IPE
2 x 1g capsules BID as per REDUCE-IT
| Study group | Role | What they receive |
|---|---|---|
| Icosapent Ethyl + Standard of Care | Experimental | Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] 2 x 1g capsules BID (4g total) as per REDUCE-IT Receives: Drug: Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] |
| Standard of Care | No intervention | Standard of care therapy (including statin therapy as per inclusion criteria) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the frequency of ALDHhiSSClowCD133+ cells in individuals treated with IPE compared to SOC for 3 months
Measured: Baseline - 3 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start24 Sep 2020
- Primary completion25 May 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Medical and Surgical Knowledge Translation Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- HLS Therapeutics, Inc, Unity Health Toronto, Western University, Canada
- Responsible party
- Sponsor
- Investigators
- Subodh Verma, MD, PhD, Principal investigator, Unity Health TorontoDavid A Hess, PhD, Principal investigator, Robarts Research Institute, London, OntarioDeepak L Bhatt, MD, MPH, Study chair, Brigham and Women's Hospital, Boston, Massachusetts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562467
- Sponsor's protocol ID
- Pro00043561
- Acronym
- IPE-PREVENTION
- Status last verified
- Mar 2024
- First submitted
- 13 Sep 2020
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mechanick JI, Farkouh ME, Newman JD, Garvey WT. Cardiometabolic-Based Chronic Disease, Adiposity and Dysglycemia Drivers: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Feb 11;75(5):525-538. doi: 10.1016/j.jacc.2019.11.044.
PubMed 32029136Carmeliet P. Angiogenesis in health and disease. Nat Med. 2003 Jun;9(6):653-60. doi: 10.1038/nm0603-653.
PubMed 12778163Bhatt 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 30415628Isner JM, Asahara T. Angiogenesis and vasculogenesis as therapeutic strategies for postnatal neovascularization. J Clin Invest. 1999 May;103(9):1231-6. doi: 10.1172/JCI6889. No abstract available.
PubMed 10225965Peichev M, Naiyer AJ, Pereira D, Zhu Z, Lane WJ, Williams M, Oz MC, Hicklin DJ, Witte L, Moore MA, Rafii S. Expression of VEGFR-2 and AC133 by circulating human CD34(+) cells identifies a population of functional endothelial precursors. Blood. 2000 Feb 1;95(3):952-8.
PubMed 10648408Takamura M, Kurokawa K, Ootsuji H, Inoue O, Okada H, Nomura A, Kaneko S, Usui S. Long-Term Administration of Eicosapentaenoic Acid Improves Post-Myocardial Infarction Cardiac Remodeling in Mice by Regulating Macrophage Polarization. J Am Heart Assoc. 2017 Feb 21;6(2):e004560. doi: 10.1161/JAHA.116.004560.
PubMed 28223437Devaraj S, Chien A, Rao B, Chen X, Jialal I. Modulation of endothelial progenitor cell number and function with n-3 polyunsaturated fatty acids. Atherosclerosis. 2013 May;228(1):94-7. doi: 10.1016/j.atherosclerosis.2013.02.036. Epub 2013 Mar 13.
PubMed 23528830Morishita T, Uzui H, Ikeda H, Amaya N, Kaseno K, Ishida K, Fukuoka Y, Lee JD, Tada H. Association of CD34/CD133/VEGFR2-Positive Cell Numbers with Eicosapentaenoic Acid and Postprandial Hyperglycemia in Patients with Coronary Artery Disease. Int J Cardiol. 2016 Oct 15;221:1039-42. doi: 10.1016/j.ijcard.2016.07.079. Epub 2016 Jul 5.
PubMed 27447811Capoccia BJ, Robson DL, Levac KD, Maxwell DJ, Hohm SA, Neelamkavil MJ, Bell GI, Xenocostas A, Link DC, Piwnica-Worms D, Nolta JA, Hess DA. Revascularization of ischemic limbs after transplantation of human bone marrow cells with high aldehyde dehydrogenase activity. Blood. 2009 May 21;113(21):5340-51. doi: 10.1182/blood-2008-04-154567. Epub 2009 Mar 26.
PubMed 19324906Putman DM, Liu KY, Broughton HC, Bell GI, Hess DA. Umbilical cord blood-derived aldehyde dehydrogenase-expressing progenitor cells promote recovery from acute ischemic injury. Stem Cells. 2012 Oct;30(10):2248-60. doi: 10.1002/stem.1206.
PubMed 22899443Terenzi DC, Al-Omran M, Quan A, Teoh H, Verma S, Hess DA. Circulating Pro-Vascular Progenitor Cell Depletion During Type 2 Diabetes: Translational Insights Into the Prevention of Ischemic Complications in Diabetes. JACC Basic Transl Sci. 2018 Nov 5;4(1):98-112. doi: 10.1016/j.jacbts.2018.10.005. eCollection 2019 Feb.
PubMed 30847424Hess DA, Terenzi DC, Trac JZ, Quan A, Mason T, Al-Omran M, Bhatt DL, Dhingra N, Rotstein OD, Leiter LA, Zinman B, Sabongui S, Yan AT, Teoh H, Mazer CD, Connelly KA, Verma S. SGLT2 Inhibition with Empagliflozin Increases Circulating Provascular Progenitor Cells in People with Type 2 Diabetes Mellitus. Cell Metab. 2019 Oct 1;30(4):609-613. doi: 10.1016/j.cmet.2019.08.015. Epub 2019 Aug 30.
PubMed 31477497Balber AE. Concise review: aldehyde dehydrogenase bright stem and progenitor cell populations from normal tissues: characteristics, activities, and emerging uses in regenerative medicine. Stem Cells. 2011 Apr;29(4):570-5. doi: 10.1002/stem.613.
PubMed 21308868Gentry T, Foster S, Winstead L, Deibert E, Fiordalisi M, Balber A. Simultaneous isolation of human BM hematopoietic, endothelial and mesenchymal progenitor cells by flow sorting based on aldehyde dehydrogenase activity: implications for cell therapy. Cytotherapy. 2007;9(3):259-74. doi: 10.1080/14653240701218516.
PubMed 17464758Shoulars K, Noldner P, Troy JD, Cheatham L, Parrish A, Page K, Gentry T, Balber AE, Kurtzberg J. Development and validation of a rapid, aldehyde dehydrogenase bright-based cord blood potency assay. Blood. 2016 May 12;127(19):2346-54. doi: 10.1182/blood-2015-08-666990. Epub 2016 Mar 11.
PubMed 26968535
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Icosapent Ethyl and Prevention of Vascular Regenerative Cell Exhaustion Study
- ClinicalTrials.gov ID
- NCT04562467
- Acronym / sponsor ID
- IPE-PREVENTION / Pro00043561
- Conditions
- Cardiovascular Diseases, Cardiovascular Risk Factor, Triglycerides High, Diabetes Mellitus, Type 2
- Keywords
- Cardiometabolic Risk, Type 2 Diabetes, Icosapent Ethyl, Omega-3, Vascular Diseases, Progenitor Cells, Vascular Disease, Blood Lipids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Canadian Medical and Surgical Knowledge Translation Research GroupUniversity, hospital or other
- Collaborators
- HLS Therapeutics, Inc, Unity Health Toronto, Western University, Canada
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 24 Sep 2020 (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.
IPE-PREVENTION is a prospective, randomized, 3-month long, open-label study. A total of 70 individuals with elevated cardio-metabolic risk and heightened triglyceride levels, and who are on stable statin therapy will be randomized (1:1) to receive either icosapent ethyl (IPE) 2g BID or standard of care.
It is hypothesized that assignment to IPE will lower progenitor cell depletion as well as limit progenitor cell dysfunction. This study may offer some molecular and cellular insights into the mechanisms underlying the cardiovascular benefits of IPE therapy reported in the REDUCE-IT trial.
Detailed description
The development and natural history of atherothrombosis involves the pathophysiological interplay between inflammation, dyslipidemia, oxidative stress and endothelial dysfunction. Unregulated, these processes culminate in endothelial dysfunction, and ultimately cardio-metabolic chronic diseases. Aberrant lipid oxidation due to elevated triglycerides and cholesterol primes and activates innate immune cell activity resulting in elevated inflammation and oxidative stress.
The randomized, placebo-controlled REDUCE-IT trial enrolled individuals with established atherosclerotic heart disease, or diabetes and an additional risk factor, who were on pre-existing statin therapy with persistent hypertriglyceridemia. REDUCE-IT reported that the group allocated to the omega-3 fatty acid icosapent ethyl (IPE; 2g BID) exhibited a 25% relative risk reduction for the primary composite endpoint of CV death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina, and a 20% decreased risk of CV death when compared to standard of care. Vascepa® (IPE) is currently approved by Health Canada and the U.S. FDA for the reduction of cardiovascular risk in statin-treated individuals with elevated triglycerides who are either at heightened cardiovascular risk or who have diabetes and at least one risk factor.
The exact mechanism through which IPE decreased cardiovascular events in REDUCE-IT has not yet been elucidated.
The population and function of circulating pro-vascular progenitor cells have been shown to benefit from diminished lipid oxidation, inflammation and oxidative stress. A healthy population of circulating pro-vascular progenitor cells in turn affords timely and efficient blood vessel repair, regeneration and atheroprotection.
The omega-3 fatty acid eicosapentaenoic acid (EPA) has been reported to inhibit M1 macrophage polarization in a murine model and increase human endothelial progenitor cell (EPC) colony formation and functionality in vitro. In vivo, EPA levels have been observed to correlate significantly with circulating EPC number (CD34+CD133+VEGFR2+ cells). Collectively, these findings affirm that EPA, and potentially omega-3 fatty acids, can enhance the number and function of circulating pro-vascular progenitor cells and can alter M1/M2 macrophage balance towards a regenerative blood vessel phenotype.
IPE-PREVENTION is a prospective, 3-month long, open-label study that will randomize a total of 70 individuals with elevated cardio-metabolic risk and heightened triglyceride levels and who are on stable statin therapy to either IPE 2g BID or standard of care. Blood samples will be collected at the baseline and month 3 visits for evaluations of cell populations in the blood as well as measurements of biomarkers that contribute to the proinflammatory and pro-oxidant milieu of individuals at elevated cardio-metabolic risk. The study will utilize the AldefluorTM assay to differentiate between and enumerate hematopoietic progenitor cells, EPCs, granulocyte precursors and macrophage precursors. The overarching goal would be to document how assignment to IPE and standard-of-care impact on circulating progenitor cell depletion and dysfunction. The effect of IPE exposure on the inflammatory and oxidative profile will also be assessed.
The results of this investigation may offer some molecular and cellular insights into the mechanisms underlying the cardiovascular benefits of IPE therapy reported in the REDUCE-IT trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icosapent Ethyl + Standard of Care | Experimental | Drug: Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] 2 x 1g capsules BID (4g total) as per REDUCE-IT |
| Standard of Care | No intervention | –Standard of care therapy (including statin therapy as per inclusion criteria) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]Also: Vascepa, IPE2 x 1g capsules BID as per REDUCE-IT | Drug | Icosapent Ethyl + Standard of Care |
Primary outcome
Change in the frequency of ALDHhiSSClowCD133+ cells in individuals treated with IPE compared to SOC for 3 months
Time frame: Baseline - 3 months post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 32029136Mechanick JI, Farkouh ME, Newman JD, Garvey WT. Cardiometabolic-Based Chronic Disease, Adiposity and Dysglycemia Drivers: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Feb 11;75(5):525-538. doi: 10.1016/j.jacc.2019.11.044.
- Background: PubMed 12778163Carmeliet P. Angiogenesis in health and disease. Nat Med. 2003 Jun;9(6):653-60. doi: 10.1038/nm0603-653.
- Background: 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.
- Background: PubMed 10225965Isner JM, Asahara T. Angiogenesis and vasculogenesis as therapeutic strategies for postnatal neovascularization. J Clin Invest. 1999 May;103(9):1231-6. doi: 10.1172/JCI6889. No abstract available.
- Background: PubMed 10648408Peichev M, Naiyer AJ, Pereira D, Zhu Z, Lane WJ, Williams M, Oz MC, Hicklin DJ, Witte L, Moore MA, Rafii S. Expression of VEGFR-2 and AC133 by circulating human CD34(+) cells identifies a population of functional endothelial precursors. Blood. 2000 Feb 1;95(3):952-8.
- Background: PubMed 28223437Takamura M, Kurokawa K, Ootsuji H, Inoue O, Okada H, Nomura A, Kaneko S, Usui S. Long-Term Administration of Eicosapentaenoic Acid Improves Post-Myocardial Infarction Cardiac Remodeling in Mice by Regulating Macrophage Polarization. J Am Heart Assoc. 2017 Feb 21;6(2):e004560. doi: 10.1161/JAHA.116.004560.
- Background: PubMed 23528830Devaraj S, Chien A, Rao B, Chen X, Jialal I. Modulation of endothelial progenitor cell number and function with n-3 polyunsaturated fatty acids. Atherosclerosis. 2013 May;228(1):94-7. doi: 10.1016/j.atherosclerosis.2013.02.036. Epub 2013 Mar 13.
- Background: PubMed 27447811Morishita T, Uzui H, Ikeda H, Amaya N, Kaseno K, Ishida K, Fukuoka Y, Lee JD, Tada H. Association of CD34/CD133/VEGFR2-Positive Cell Numbers with Eicosapentaenoic Acid and Postprandial Hyperglycemia in Patients with Coronary Artery Disease. Int J Cardiol. 2016 Oct 15;221:1039-42. doi: 10.1016/j.ijcard.2016.07.079. Epub 2016 Jul 5.
- Background: PubMed 19324906Capoccia BJ, Robson DL, Levac KD, Maxwell DJ, Hohm SA, Neelamkavil MJ, Bell GI, Xenocostas A, Link DC, Piwnica-Worms D, Nolta JA, Hess DA. Revascularization of ischemic limbs after transplantation of human bone marrow cells with high aldehyde dehydrogenase activity. Blood. 2009 May 21;113(21):5340-51. doi: 10.1182/blood-2008-04-154567. Epub 2009 Mar 26.
- Background: PubMed 22899443Putman DM, Liu KY, Broughton HC, Bell GI, Hess DA. Umbilical cord blood-derived aldehyde dehydrogenase-expressing progenitor cells promote recovery from acute ischemic injury. Stem Cells. 2012 Oct;30(10):2248-60. doi: 10.1002/stem.1206.
- Background: PubMed 30847424Terenzi DC, Al-Omran M, Quan A, Teoh H, Verma S, Hess DA. Circulating Pro-Vascular Progenitor Cell Depletion During Type 2 Diabetes: Translational Insights Into the Prevention of Ischemic Complications in Diabetes. JACC Basic Transl Sci. 2018 Nov 5;4(1):98-112. doi: 10.1016/j.jacbts.2018.10.005. eCollection 2019 Feb.
- Background: PubMed 31477497Hess DA, Terenzi DC, Trac JZ, Quan A, Mason T, Al-Omran M, Bhatt DL, Dhingra N, Rotstein OD, Leiter LA, Zinman B, Sabongui S, Yan AT, Teoh H, Mazer CD, Connelly KA, Verma S. SGLT2 Inhibition with Empagliflozin Increases Circulating Provascular Progenitor Cells in People with Type 2 Diabetes Mellitus. Cell Metab. 2019 Oct 1;30(4):609-613. doi: 10.1016/j.cmet.2019.08.015. Epub 2019 Aug 30.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Subodh Verma, MD, PhD principal investigator
Unity Health Toronto
David A Hess, PhD principal investigator
Robarts Research Institute, London, Ontario
Deepak L Bhatt, MD, MPH study chair
Brigham and Women's Hospital, Boston, Massachusetts
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by Canadian Medical and Surgical Knowledge Translation Research Group at 3 sites in Canada.
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 31 inclusion and 24 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: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the frequency of ALDHhiSSClowCD133+ cells in individuals treated with IPE compared to SOC for 3 months (time frame: Baseline - 3 months post-randomization). 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 NCT04562467, which also lists 16 linked publications.
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 2 Apr 2024.