KCT0005577终止未知
Efficacy and Safety of Evolocumab prior to CABG in multivessel coronary artery disease: A prospective, randomized, open, controlled, multicenter, phase 3 clinical trial
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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)
研究者
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