ACTRN12612000340831尚未招募4 期
A randomised controlled trial of Ivabradine and Atorvastatin in emergent orthopaedic lower limb surgery for neck of femur fracture in elderly patients: a mechanistic study of peri-operative myocardial injury and its prevention using computed tomography coronary plaque imaging and novel biomarkers of cardiovascular stress and lipid metabolism
orthern hospital0 个研究点目标入组 200 人开始时间: 2012年3月23日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
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
- Open (masking not used)
入排标准
- 年龄范围
- 60 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Age greater than 60 years
- •2) Neck of femur fracture with planned surgical treatment within 48 hours
排除标准
- •1) Current ivabradine use
- •2) Patients who do not undergo surgical treatment for lower limb fracture for any reason. If such patients were initially enrolled they will be excluded from the analysis, i.e per protocol analysis.
- •3) Heart rate < 65bpm prior to randomisation
- •4) Known liver disease or liver enzymes > 3 times the higher limits of normal
- •5) Pre-operative troponin elevation
- •6) Artificial pacemakers, sick sinus syndrome or complete heart block
- •7) Concomittant CYP3A4 inhibitors – ketoconazole, macrolides, cyclosporin, gestodene, antiretrovirals
研究者
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