The Effect Of Acadesine On Clinically Significant Adverse Cardiovascular and Cerebrovascular Events In High-Risk Subjects Undergoing Coronary Artery Bypass Graft (CABG) Surgery Using Cardiopulmonary Bypass (Protocol No. P05633): RED-CABG Trial (Reduction in Cardiovascular Events by AcaDesine in Subjects Undergoing CABG)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3,080
- 主要终点
- Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population)
研究概览
简要总结
The purpose of this study is to determine whether acadesine is effective in reducing the cardiovascular and cerebrovascular adverse events in high-risk participants undergoing CABG surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A high risk participant undergoing non emergency CABG surgery requiring CPB and cardioplegia.
- •Age: >=50 years
- •At least one of the following risk factors:
- •Female (but not pregnant or lactating), or
- •History of prior CABG, or
- •History of myocardial infarction (MI), or
- •History of ischemic stroke, or
- •Left ventricular ejection fraction <=30%, or
- •Diabetes mellitus requiring insulin and/or antidiabetic agents.
- •Significant coronary artery stenosis
排除标准
- •Planned valve replacement, carotid artery or aortic surgery, distal coronary endarterectomy,surgical ablation for cardiac arrhythmia, or ventricular aneurysmectomy, alone or with CABG surgery (repair for mild to moderate mitral valve disease with concomitant CABG is not excluded).
- •Planned or staged major surgery within 30 days of CABG surgery
- •CABG surgery using intermittent aortic cross clamping without cardioplegia.
- •Minimally invasive surgery (ie, without use of CPB).
- •MI within 5 days prior to surgery.
- •Pre-operative or planned intra operative/postoperative use of intra-aortic balloon pump (IABP), ventricular assist device (VAD), extra-corporeal membrane oxygenator (ECMO), or other mechanical hemodynamic assist device.
- •History or presence of gout or uric acid nephrolithiasis.
- •Serum creatinine >2 mg/dL (180 µmol/L).
- •Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 x Upper Limit of Normal (ULN).
- •Adenosine, aminophylline, nicotinic acid, pentoxifylline, theophylline, and any cardioplegia solution containing adenosine, dipyridamole or lidoflazine within 24 hours before surgery:
- •Dipyridamole within 2 days and allopurinol or febuxostat within 4 days before surgery
- •Food and drinks containing caffeine, theobromines or methylxanthines (such as coffee, tea, colas, some 'energy' drinks or chocolate) within 12 hours before surgery.
- •Pregnancy
研究组 & 干预措施
Acadesine
Acadesine intravenous (IV) infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
干预措施: Acadesine (Drug)
Placebo
Normal saline, IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
干预措施: Normal Saline (Drug)
结局指标
主要结局
Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population)
时间窗: Up to Post-Operative Day 28
Incidence of all-cause death, non-fatal stroke, or need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: All-cause death: Death from any cause, Non-fatal Stoke: occurrence of a stoke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.
次要结局
- Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population)(Up to Post-Operative Day 28)