The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease
NCT ID: NCT03829046
Last Updated: 2023-03-08
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
41 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-06-03
Study Completion Date
2021-11-15
Brief Summary
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Experimental models have linked lipid lowering therapies with systemic inflammation; however, relatively little is known about this network in clinical populations and specifically how it changes with PCSK9 inhibition. The eligible subjects will have 6 visits in 13 to 16 weeks and will have Repatha/placebo 140mg subcutaneous every 4 weeks for 3 times since randomization visit, blood tests will be done in each visit to evaluate the effects of evolocumab upon biocellular markers potentially altered by PCSK9 inhibition in a population of type 2 diabetes patients with microvascular dysfunction.
Primary Aims:
Determine the ACUTE and SHORT-TERM effects of PCSK9 inhibition with evolocumab on biocellular markers of inflammation, immune mediated thrombosis and rheology. The data from this trial will be used to support a clinical trial to assess the role of PCSK9 inhibition in type 2 diabetes patients with cardiac microvascular dysfunction.
Secondary Aims:
1. To define the association between PCSK 9 concentrations and immune-related phenotype.
2. To define the association between Lp(a) concentrations, oxidized phospholipids (OxPL), ApoB, biocellular markers of inflammation, tissue factor and immunothrombosis.
Primary Aims:
Determine the ACUTE and SHORT-TERM effects of PCSK9 inhibition with evolocumab on biocellular markers of inflammation, immune mediated thrombosis and rheology. The data from this trial will be used to support a clinical trial to assess the role of PCSK9 inhibition in type 2 diabetes patients with cardiac microvascular dysfunction.
Secondary Aims:
1. To define the association between PCSK 9 concentrations and immune-related phenotype.
2. To define the association between Lp(a) concentrations, oxidized phospholipids (OxPL), ApoB, biocellular markers of inflammation, tissue factor and immunothrombosis.
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Detailed Description
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Multi-center, double-blind, randomized, placebo-controlled, parallel group Phase IV study with two treatment arms: evolocumab SC 420 mg/dL QM or matching placebo. The population will include 40 participants with documented Atherosclerotic Vascular Disease (CAD, Stroke, PAD) and type 2 diabetes who receive treatment with maximal tolerated statin therapy and stable doses of anti-hyperglycemic therapy.
Subjects will be followed for 12 weeks during the treatment phase, maintaining the double-blind throughout. Assessments of ACUTE and SHORT-TERM effects of PCSK9 inhibition with evolocumab on biocellular markers of endothelial function will be measured at baseline, Week 2, and Week 12. Safety assessments will be undertaken at each study visit.
Subjects will be followed for 12 weeks during the treatment phase, maintaining the double-blind throughout. Assessments of ACUTE and SHORT-TERM effects of PCSK9 inhibition with evolocumab on biocellular markers of endothelial function will be measured at baseline, Week 2, and Week 12. Safety assessments will be undertaken at each study visit.
Conditions
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Atherosclerotic Vascular Disease
Type2 Diabetes
Microvascular Dysfunction
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
A multi-center, double-blind, randomized, placebo-controlled, parallel group Phase IV study with two treatment arms: evolocumab SC 420 mg/dL QM or matching placebo. The identity of the treatments will be concealed by the use of matching placebo to the study drug that are identical in packaging, labeling, appearance and schedule of administration.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
The identity of the treatments will be concealed by the use of matching placebo to the study drug that are identical in packaging, labeling, appearance and schedule of administration.
Study Groups
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Placebo
Placebo SC QM
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
12 weeks of treatment
Evolocumab
Evolocumab SC 420mg/dL QM
Group Type
ACTIVE_COMPARATOR
Evolocumab
Intervention Type
DRUG
12 weeks of treatment
Interventions
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Placebo
12 weeks of treatment
Intervention Type
DRUG
Evolocumab
12 weeks of treatment
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Subjects ≥18 years of age signing of informed consent;
* A history of clinical ASCVD, which is defined as: acute coronary syndrome, or a history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial disease presumed to be of atherosclerotic origin;
* Clinical diagnosis of type 2 diabetes according to ADA/ CDA guidelines;
* Subject on stable dose of maximally-tolerated statin therapy for ≥4 weeks prior to screening and LDL-c ≥70mg/dL. For subjects whose maximally tolerated dose of statin is no type or dose (i.e. determined to be statin intolerant by primary investigator), background lipid-lowering therapy is not required;
* Fasting triglycerides ≤400mg/dL (4.52mmol/L) by central laboratory at screening;
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures;
* Abnormal urinary Albumin Creatinine Ratio (ACR) as defined by an ACR ≥2;
* Subject tolerates screening placebo injection.
* A history of clinical ASCVD, which is defined as: acute coronary syndrome, or a history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial disease presumed to be of atherosclerotic origin;
* Clinical diagnosis of type 2 diabetes according to ADA/ CDA guidelines;
* Subject on stable dose of maximally-tolerated statin therapy for ≥4 weeks prior to screening and LDL-c ≥70mg/dL. For subjects whose maximally tolerated dose of statin is no type or dose (i.e. determined to be statin intolerant by primary investigator), background lipid-lowering therapy is not required;
* Fasting triglycerides ≤400mg/dL (4.52mmol/L) by central laboratory at screening;
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures;
* Abnormal urinary Albumin Creatinine Ratio (ACR) as defined by an ACR ≥2;
* Subject tolerates screening placebo injection.
Exclusion Criteria
* Personal or family history of hereditary muscular disorders;
* NYHA III or IV heart failure, or last know left ventricular ejection fraction (LVEF) \<30%;
* Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 6 weeks prior to randomization;
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery graft (CABG) or stroke within 3 months prior to randomization;
* Planned cardiac surgery or revascularization;
* Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \<30mL/min/1.73m2 at screening;
* Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c \>10%), newly diagnosed type 2 diabetes (within 6 months of randomization), or laboratory evidence of diabetes during screening (fasting serum glucose ≥126mg/dL \[7.0mmol/L\] or HbA1c ≥6.5% without prior diagnosis of diabetes;
* Uncontrolled hypertension, defined as sitting systolic blood pressure (SBP) \>160mmHg or diastolic BP (DBP) \>100mmHg;
* Subject who has taken a cholesterol easter transfer protein (CETP) inhibitor in the last 12 months prior to LDL-c screening, such as: anacetrapib, dalcetrapib or evacetrapib;
* Treatment in the last 3 months prior to LDL-c screening with any of the following drugs: systemic cyclosporine, systemic steroids (e.g. IV, intramuscular \[IM\], or PO) (Note: hormone replacement therapy is permitted), vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions (e.g. Accutane); (Note: vitamin A in a multivitamin preparation is permitted). Topical retinol prescription and non-prescription derivatives or creams are permitted;
* Uncontrolled hypothyroidism or hyperthyroidism as defined by thyroid stimulating hormone (TSH) \<1.0 time the lower limit of normal or \>1.5 times the ULN, respectively, at screening. Potential subjects with TSH \<1.0 time the lower limit of normal due to thyroid replacement therapy is not considered an exclusion;
* Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 times the ULN as determined by central laboratory analysis at screening;
* Known active infection or major hematologic, renal metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator;
* Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months prior to randomization;
* Unreliability as a study participant based on the investigator's (or designee's) knowledge of the subject (e.g. alcohol or other drug abuse);
* Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s);
* Female subject who has either (1) not used at least 1 highly effective method of contraception for at least 1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilized or postmenopausal;
* Subject who is pregnant or breast feeding, or planning to become pregnant during treatment and/ or within 15 weeks after the end of treatment;
* Use of PCSK9 inhibitor within 10 weeks from screening;
* Subject who has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures;
* Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years;
* Subject who has known sensitivity to any of the products or components to be administered during dosing;
* Subject who is likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge;
* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the principal investigator would pose a risk to subject or interfere with the study evaluation, procedures or completion;
* Blood donation 4 weeks prior to screening, or stated intention to donate blood or blood products during the period of the study or within one month following completion of the study;
* Subjects who have participated in other studies within 30 days prior to screening, or have five times the plasma half-life (if known) of the investigational drug, whichever is longer;
* BMI\>40kg/m2.
* NYHA III or IV heart failure, or last know left ventricular ejection fraction (LVEF) \<30%;
* Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 6 weeks prior to randomization;
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery graft (CABG) or stroke within 3 months prior to randomization;
* Planned cardiac surgery or revascularization;
* Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \<30mL/min/1.73m2 at screening;
* Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c \>10%), newly diagnosed type 2 diabetes (within 6 months of randomization), or laboratory evidence of diabetes during screening (fasting serum glucose ≥126mg/dL \[7.0mmol/L\] or HbA1c ≥6.5% without prior diagnosis of diabetes;
* Uncontrolled hypertension, defined as sitting systolic blood pressure (SBP) \>160mmHg or diastolic BP (DBP) \>100mmHg;
* Subject who has taken a cholesterol easter transfer protein (CETP) inhibitor in the last 12 months prior to LDL-c screening, such as: anacetrapib, dalcetrapib or evacetrapib;
* Treatment in the last 3 months prior to LDL-c screening with any of the following drugs: systemic cyclosporine, systemic steroids (e.g. IV, intramuscular \[IM\], or PO) (Note: hormone replacement therapy is permitted), vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions (e.g. Accutane); (Note: vitamin A in a multivitamin preparation is permitted). Topical retinol prescription and non-prescription derivatives or creams are permitted;
* Uncontrolled hypothyroidism or hyperthyroidism as defined by thyroid stimulating hormone (TSH) \<1.0 time the lower limit of normal or \>1.5 times the ULN, respectively, at screening. Potential subjects with TSH \<1.0 time the lower limit of normal due to thyroid replacement therapy is not considered an exclusion;
* Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 times the ULN as determined by central laboratory analysis at screening;
* Known active infection or major hematologic, renal metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator;
* Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months prior to randomization;
* Unreliability as a study participant based on the investigator's (or designee's) knowledge of the subject (e.g. alcohol or other drug abuse);
* Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s);
* Female subject who has either (1) not used at least 1 highly effective method of contraception for at least 1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilized or postmenopausal;
* Subject who is pregnant or breast feeding, or planning to become pregnant during treatment and/ or within 15 weeks after the end of treatment;
* Use of PCSK9 inhibitor within 10 weeks from screening;
* Subject who has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures;
* Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years;
* Subject who has known sensitivity to any of the products or components to be administered during dosing;
* Subject who is likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge;
* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the principal investigator would pose a risk to subject or interfere with the study evaluation, procedures or completion;
* Blood donation 4 weeks prior to screening, or stated intention to donate blood or blood products during the period of the study or within one month following completion of the study;
* Subjects who have participated in other studies within 30 days prior to screening, or have five times the plasma half-life (if known) of the investigational drug, whichever is longer;
* BMI\>40kg/m2.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Amgen
INDUSTRY
Sponsor Role
collaborator
University of Toronto
OTHER
Sponsor Role
collaborator
University of Michigan
OTHER
Sponsor Role
collaborator
Robert Rosenson
OTHER
Sponsor Role
lead
Responsible Party
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Robert Rosenson
Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Robert Rosenson, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Kim A Connelly, MD
Role: PRINCIPAL_INVESTIGATOR
St. Michael's Hospital at University of Toronto
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Site Status
St. Michael's - University of Toronto
Toronto, Ontario, Canada
Site Status
Countries
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United States
Canada
References
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Tall AR, Yvan-Charvet L. Cholesterol, inflammation and innate immunity. Nat Rev Immunol. 2015 Feb;15(2):104-16. doi: 10.1038/nri3793.
Reference Type
BACKGROUND
Chatzizisis YS, Coskun AU, Jonas M, Edelman ER, Feldman CL, Stone PH. Role of endothelial shear stress in the natural history of coronary atherosclerosis and vascular remodeling: molecular, cellular, and vascular behavior. J Am Coll Cardiol. 2007 Jun 26;49(25):2379-93. doi: 10.1016/j.jacc.2007.02.059. Epub 2007 Jun 8.
Reference Type
BACKGROUND
Dai G, Kaazempur-Mofrad MR, Natarajan S, Zhang Y, Vaughn S, Blackman BR, Kamm RD, Garcia-Cardena G, Gimbrone MA Jr. Distinct endothelial phenotypes evoked by arterial waveforms derived from atherosclerosis-susceptible and -resistant regions of human vasculature. Proc Natl Acad Sci U S A. 2004 Oct 12;101(41):14871-6. doi: 10.1073/pnas.0406073101. Epub 2004 Oct 4.
Reference Type
BACKGROUND
Traub O, Berk BC. Laminar shear stress: mechanisms by which endothelial cells transduce an atheroprotective force. Arterioscler Thromb Vasc Biol. 1998 May;18(5):677-85. doi: 10.1161/01.atv.18.5.677.
Reference Type
BACKGROUND
Nahrendorf M, Pittet MJ, Swirski FK. Monocytes: protagonists of infarct inflammation and repair after myocardial infarction. Circulation. 2010 Jun 8;121(22):2437-45. doi: 10.1161/CIRCULATIONAHA.109.916346. No abstract available.
Reference Type
BACKGROUND
Chang HN, Leroueil PR, Selwa K, Gasper CJ, Tsuchida RE, Wang JJ, McHugh WM, Cornell TT, Baker JR Jr, Goonewardena SN. Profiling inflammatory responses with microfluidic immunoblotting. PLoS One. 2013 Nov 27;8(11):e81889. doi: 10.1371/journal.pone.0081889. eCollection 2013.
Reference Type
BACKGROUND
Rosenson RS, Tate A, Mar P, Grushko O, Chen Q, Goonewardena SN. Inhibition of PCSK9 with evolocumab modulates lipoproteins and monocyte activation in high-risk ASCVD subjects. Atherosclerosis. 2024 May;392:117529. doi: 10.1016/j.atherosclerosis.2024.117529. Epub 2024 Mar 25.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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https://www.nature.com/articles/nature01323
Inflammation in atherosclerosis
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4361218/
Hemodynamic Shear Stress via ROS Modulates PCSK9 Expression in Human Vascular Endothelial and Smooth Muscle Cells and Along the Mouse Aorta.
https://www.ncbi.nlm.nih.gov/pubmed/26333678
Local effects of human PCSK9 on the atherosclerotic lesion.
Other Identifiers
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20167719
Identifier Type: OTHER
Identifier Source: secondary_id
GCO 18-1412
Identifier Type: -
Identifier Source: org_study_id
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