Myocardial protective effect of evolocumab prior to coronary artery bypass grafting

Not Applicable

Terminated

• Conditions: Not Applicable

• Registration Number: KCT0005577
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-30
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 100

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

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 < 12 weeks prior to screening.
5. 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 final screening
6. Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 at final screening
7. Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal)
8. CK > 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)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak level of Troponin-I

Secondary Outcome Measures

Name	Time	Method
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