Phase
Condition
Atherosclerosis
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria - To be considered eligible for participation in this study, aparticipant must satisfy each of the following criteria:
Age ≥ 18 years
Scheduled to undergo coronary artery bypass graft (CABG) surgery (with or withoutcardiopulmonary bypass (CPB); with or without single valve repair/replacement)
CABG procedure included/planned to include at least two saphenous vein grafts
CABG procedure occurred within the past 21 days, or is planned within the next 60 days
On a moderate to high intensity statin therapy (defined as atorvastatin 40-80mg daily,rosuvastatin 20-40mg or simvastatin 40mg daily) unless a lower dose, or another statinor non-statin therapy is clinically justified Exclusion Criteria - A participant will be ineligible for participation in this study if heor she satisfies any one or more of the following criteria:
Patients in whom additional lowering of LDL-C with evolocumab is deemed to beclinically inappropriate
Allergy to contrast dye
Known severe hepatic impairment (Childs-Pugh, Class C).
Known renal disease with estimated glomerular filtration rate (eGFR) < 30mL/min/1.73m2
Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow)
Use of cholesterylester transfer protein (CETP) inhibition treatment within 12 monthsprior to randomization.
Current, prior within past year, or known planned use of PCSK9 inhibition treatment
Severe cardiovascular or concomitant non-cardiovascular disease that is expected toreduce life expectancy to less than 2 years
Major active infection, or major hematologic, renal, respiratory, metabolic,gastrointestinal or endocrine dysfunction
Women who are pregnant or breastfeeding
Women of child bearing potential who are unwilling to use proper family planning orbirth control methods to avoid pregnancy. Women are considered post-menopausal and notof childbearing potential after 12 months of natural (spontaneous) amenorrhea or havehad a surgical procedure such as hysterectomy which makes pregnancy impossible.
Known intolerance or allergy to evolocumab or other PCSK9 inhibitors.
Currently taking simvastatin >40mg/day, niacin or bile acid sequestrants
Known latex allergy
Inability to comply with protocol-required study visits or procedures, includingadministration of study drug
Known history of cancer within the past 5 years (except for carcinoma in-situ of thecervix, stage 1 prostate cancer or adequately treated non-melanoma carcinomas of theskin)
Participation in another investigational device or drug study which is likely toaffect the primary outcome, within 30 days of planned initiation of study drug
NYHA class IV
Pacemaker or other implantable device implanted within 30 days prior to screening
Exclusion
Additional postoperative exclusion criteria:
Received only <2 vein grafts
Major peri-operative complications following CABG surgery (e.g. stroke, MI, renalfailure requiring dialysis, or postoperative ICU stay > 5 days) prior to randomization
Study Design
Study Description
Connect with a study center
University of Alberta
Edmonton, Alberta T6G 2R8
CanadaActive - Recruiting
Hamilton Health Sciences
Hamilton, Ontario
CanadaActive - Recruiting
Kingston Health Sciences Centre
Kingston, Ontario K7L 2V7
CanadaActive - Recruiting
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaActive - Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec
CanadaActive - Recruiting
Foothills Medical Centre
Calgary,
CanadaActive - Recruiting
Yale University School of Medicine
New Haven, Connecticut 06511
United StatesActive - Recruiting
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
United StatesActive - Recruiting
Maine Medical Center
Portland, Maine 04102
United StatesActive - Recruiting
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