Patency of graft after coronary bypass graft surgery in patients with hyprelipidaemia MedDRA version: 20.0 Level: LLT Classification code 10011079 Term: Coronary artery disease NOS System Organ Class: 100000004849
Conditions
Interventions
Product Name: Repatha
Pharmaceutical Form: Solution for injection in pre-filled injector
Pharmaceutical form of the placebo: Solution for injection in pre-filled injector
Route of administration of th
Sponsors
Unity Health Toronto, at its St. Michael’s site
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be considered eligible for participation in this study, a participant must satisfy each of the following criteria: 1. Age = 18 years 2. Scheduled to undergo coronary artery bypass graft (CABG) surgery (with or without cardiopulmonary bypass (CPB); with or without single valve repair/replacement) 3. CABG procedure included/planned to include at least two saphenous vein grafts 4. CABG procedure occurred within the past 21 days, or is planned within the next 60 days 5. On a moderate to high intensity statin therapy (defined as atorvastatin 40-80 mg daily, rosuvastatin 20-40 mg, or simvastatin 40 mg daily) unless a lower dose, or another statin or non-statin therapy is clinically justified Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 466
Exclusion criteria
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: 1. Patients in whom additional lowering of LDL-C with evolocumab is deemed to be clinically inappropriate 2. Allergy to contrast dye 3. Known severe hepatic impairment (Childs-Pugh, Class C). 4. Known renal disease with estimated glomerular filtration rate (eGFR) 40 mg/day, niacin or bile acid sequestrants 14. Known latex allergy 15. Inability to comply with protocol-required study visits or procedures, including administration of study drug 16. Known history of cancer within the past 5 years (except for carcinoma in- situ of the cervix, stage 1 prostate cancer or adequately treated non-melanoma carcinomas of the skin) 17. Participation in another investigational device or drug study which is likely to affect the primary outcome, within 30 days of planned initiation of study drug 18. NYHA class IV 19. Pacemaker or other implantable device implanted within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Given that graft failure is associated with increased morbidity and mortality, and that lipid lowering interventions may reduce vein graft occlusion, the objectives of this study are to determine if intensive LDL-cholesterol lowering with evolocumab will result in improved vein graft patency compared to placebo following CABG surgery.;Secondary Objective: None;Primary end point(s): The primary endpoint of the study is the saphenous vein graft disease rate (VGDR) defined as the proportion of vein grafts with significant stenosis or total occlusion (=50%) on 64-slice (or greater) cardiac CT angiography (CTA) or clinically indicated coronary angiography 24 months post CABG. ;Timepoint(s) of evaluation of this end point: At the end of 24th month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of patients with at least 1 vein graft totally (100%) occluded at 24 months • The percentage of vein grafts which are totally occluded (100%) grafts at 24 months ;Timepoint(s) of evaluation of this end point: At the end of 24th month | — |
Countries
Australia, Canada, Hungary, United States
Contacts
Public ContactKornelia Dr Szabone Dr Szasz
Szasz es Tarsa Egeszsegugyi es Szolgaltato Beteti Tarsasag
Outcome results
None listed