ACTRN12619000658112尚未招募2 期
A Phase II Randomised, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Oral NP202 in Reducing the Incidence of Atrial Fibrillation in Adults who have undergone Cardiac Surgery.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 70 Years 至 o limit（—）
- 性别
- All
入选标准
- •Are male or female and aged at least 70 years old at the time of consent.
- •Are scheduled for coronary arterial bypass graft and/or valve replacement surgery
- •Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.
排除标准
- •Clinical history of chronic or paroxysmal atrial fibrillation.
- •Estimated glomerular filtration rate (eGFR) <30ml/min
- •Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of IP.
- •History of severe or life-threatening drug allergy and/or known drug hypersensitivity.
- •Current malignancy or previous malignancy that is likely to recur during the period of the study (with the exception of a past history of basal or squamous cell carcinomas).
- •Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C (note these will not be tested for)
- •Other than the protocol indication, history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological, autoimmune or psychological disorder that, in the investigator’s opinion, would compromise subject safety or protocol compliance
研究者
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