Phase
Condition
Atherosclerosis
Treatment
Evolocumab
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria - To be considered eligible for participation in this study, a participant 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 60days
On a moderate to high intensity statin therapy (defined as atorvastatin 40-80mgdaily, rosuvastatin 20-40mg or simvastatin 40mg daily) unless a lower dose, oranother statin or non-statin therapy is clinically justified
Exclusion Criteria - A participant will be ineligible for participation in this study if he or 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 12months prior 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 andnot of childbearing potential after 12 months of natural (spontaneous) amenorrhea orhave had 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 torandomization
Study Design
Study Description
Connect with a study center
Royal Adelaide Hospital
Adelaide,
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide 2078025,
AustraliaSite Not Available
Flinders Medical Centre
Bedford Park,
AustraliaSite Not Available
Flinders Medical Centre
Bedford Park 2076918,
AustraliaSite Not Available
Monash University
Melbourne,
AustraliaSite Not Available
Monash University
Melbourne 2158177,
AustraliaSite Not Available
Fiona Stanley Hospital
Murdoch,
AustraliaSite Not Available
Fiona Stanley Hospital
Murdoch 8349091,
AustraliaSite Not Available
University of Alberta
Edmonton, Alberta T6G 2R8
CanadaSite Not Available
University of Alberta
Edmonton 5946768, Alberta 5883102 T6G 2R8
CanadaSite Not Available
New Brunswick Heart Centre
Saint John's, New Brunswick 6087430
CanadaSite Not Available
Hamilton Health Sciences
Hamilton, Ontario
CanadaSite Not Available
Kingston Health Sciences Centre
Kingston, Ontario K7L 2V7
CanadaSite Not Available
One Heart Care
Mississauga, Ontario
CanadaSite Not Available
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaSite Not Available
Hamilton Health Sciences
Hamilton 5969782, Ontario 6093943
CanadaSite Not Available
Kingston Health Sciences Centre
Kingston 5992500, Ontario 6093943 K7L 2V7
CanadaSite Not Available
One Heart Care
Mississauga 6075357, Ontario 6093943
CanadaSite Not Available
North York Diagnostic and Cardiology Centre
North York, Ontario 6093943
CanadaSite Not Available
Sunnybrook Health Sciences Center
North York, Ontario 6093943
CanadaSite Not Available
St. Michael's Hospital
Toronto 6167865, Ontario 6093943 M5B 1W8
CanadaSite Not Available
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec
CanadaSite Not Available
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec 6325494, Quebec 6115047
CanadaSite Not Available
Foothills Medical Centre
Calgary,
CanadaSite Not Available
Foothills Medical Centre
Calgary 5913490,
CanadaSite Not Available
Medical Centre Hungarian Defence Forces
Budapest,
HungarySite Not Available
Semmelweis University Heart and Vascular Centre
Budapest,
HungarySite Not Available
Medical Centre Hungarian Defence Forces
Budapest 3054643,
HungarySite Not Available
Semmelweis University Heart and Vascular Centre
Budapest 3054643,
HungarySite Not Available
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg,
HungarySite Not Available
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg 3042638,
HungarySite Not Available
San Francisco VA Medical Center
San Francisco, California 94121
United StatesSite Not Available
San Francisco VA Medical Center
San Francisco 5391959, California 5332921 94121
United StatesSite Not Available
Yale University School of Medicine
New Haven, Connecticut 06511
United StatesSite Not Available
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
United StatesSite Not Available
Jacksonville Center for Clinical Research
Jacksonville 4160021, Florida 4155751 32216
United StatesSite Not Available
Maine Medical Center
Portland, Maine 04102
United StatesSite Not Available
Maine Medical Center
Portland 4975802, Maine 4971068 04102
United StatesSite Not Available
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
United StatesSite Not Available
Minneapolis Heart Institute Foundation
Minneapolis 5037649, Minnesota 5037779 55407
United StatesSite Not Available
University Hospital Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
University Hospital Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available

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