None listed
Conditions
Interventions
Drug : Evolocumab (Repatha) 140mg
140mg/day (1pen), once, subcutaneous injection
The control group will not receive any placebo medication.
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 18, <85 years 2. Multivessel coronary artery disease patients awaiting elective cardiac surgery without elevation of serum cardiac enzymes. 3. The patient or legal representative must sign the consent form before the procedure, in form containing all the details of the research approved by the Ethics Committee of the Institution.
Exclusion criteria
Exclusion criteria: 1. Patients who underwent any open heart surgery before. 2. Patients requiring concomitant valve surgery. 3. Patients with acute myocardial infarction 4. Prior use of PCSK9 inhibition treatment other than evolocumab or use of evolocumab 3 times the ULN as determined by central laboratory analysis at final screening 6. Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) 5 times the ULN at final screening 9. Known major active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator 10. Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 10 years 11. Subject is pregnant or breast feeding, or planning to become pregnant or to breastfeed during treatment with IP and/ or within 15 weeks after the end of treatment with IP Subject likely to not be available to complete all protocol-required study visits or procedures, to the best of the subject’s and investigator’s knowledge 12. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak level of Troponin-I | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC of Troponin-I;Change of Troponin-I;Peak level of CK-MB;AUC of CK-MB;Change of CK-MB;Change of BNP;Change of CRP;Change of LVEF;Cumulated incidence of all-cause mortality;Cumulated incidence of myocardial infarction;Cumulated incidence of stroke including hemorrhagic, ischemic stroke and TIA;Cumulated incidence of atrial fibrillation;Cumulated incidence of coronary revascularization including PCI and CABG | — |
Countries
Korea, Republic of
Contacts
Public ContactJu Yong Lim
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed