秋水仙碱对心肌梗死患者的影响
低剂量秋水仙碱对心肌梗死患者的疗效:一项随机对照试验
在过去几年中,大量证据表明炎症过程是 ST 段抬高型心肌梗死 (STEMI) 患者缺血/再灌注相关现象有害影响的关键介质。 然而,同样令人印象深刻的是缺乏临床适用的治疗策略来减轻这些过程,从而提供显着的心脏保护作用。 尽管众所周知炎症在冠状动脉疾病的发展和进展中起着重要作用,但很少有人尝试系统地检查抗炎治疗在这种情况下的潜在作用,这可能是因为缺乏抗炎药没有皮质类固醇和非甾体类抗炎药的不良心血管安全性。 秋水仙碱是一种具有强大抗炎特性的物质,具有独特的作用机制,可安全用于心血管疾病患者。
本临床研究的目的是检验秋水仙碱短期治疗可减少急性 MI 患者主要不良心血管事件 (MACE) 的假设。
研究概览
详细说明
在过去几年中,大量证据表明炎症过程是 ST 段抬高型心肌梗死 (STEMI) 患者缺血/再灌注相关现象有害影响的关键介质。 然而,同样令人印象深刻的是缺乏临床适用的治疗策略来减轻这些过程,从而提供显着的心脏保护作用。
尽管众所周知炎症在冠状动脉疾病的发展和进展中起着重要作用,但很少有人尝试系统地检查抗炎治疗在这种情况下的潜在作用,这可能是因为缺乏抗炎药没有皮质类固醇和非甾体类抗炎药的不良心血管安全性。 一些抗炎药,如 pexelizumab,专注于补体级联反应。另一种药物是 Varespladib,它靶向引起氧化应激和炎症的 sPLA2。 还有其他治疗靶点已被广泛研究。 秋水仙碱是一种具有强大抗炎特性的物质,具有独特的作用机制,可安全用于心血管疾病患者。
秋水仙碱与非聚合的微管蛋白结合,形成稳定的复合物,有效抑制微管的动态,使其解聚。 因此,任何需要改变细胞骨架的过程,例如细胞有丝分裂、胞吐作用和中性粒细胞运动,都会受到影响。 秋水仙碱对心房肌细胞有重要作用,改变心房对自主神经作用的反应(减少交感神经活动并增加副交感神经活动)。 由于这种特殊的作用方式,秋水仙碱已被用于治疗心脏手术后的房颤。 正在进行一项类似的试验,以调查心肌梗塞后发生的任何积液或综合征。
本临床研究的目的是检验秋水仙碱短期治疗可减少急性 MI 患者主要不良心血管事件 (MACE) 的假设。
研究类型
阶段
- 阶段2
联系人和位置
学习地点
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Rawalpindi、巴基斯坦、46000
- Rawalpindi Institute of Cardiology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 所有在急诊科就诊的急性心肌梗死患者均年满 18 岁。 这些患者将被要求在稳定和管理后出院时服药
排除标准:
- 30 天前有过心肌梗死史的患者
- 缺血性心肌病患者
- 年龄 <18 岁或 > 80 岁
- 活动性炎症或传染病或已知的恶性肿瘤
- 已知对秋水仙碱过敏,
- 肾功能衰竭(eGFR <30ml.min.1.73m)
- 肝衰竭
- 支架内血栓
- 出现心脏骤停或心源性休克症状
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:秋水仙碱组
该组将接受低剂量秋水仙碱,0.5 毫克。
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在研究期间每天服用一次药片
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安慰剂比较:安慰剂组
该组将接受与实验药物形状和质量相似的安慰剂药物
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在研究期间每天服用一次药片
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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主要心血管不良事件(事件数)
大体时间:3个月
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这一结果将使用问卷进行评估。 将使用以下标题:
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3个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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肌钙蛋白 I (ng/ml)
大体时间:3个月
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该检查将作为数值记录在同一份问卷上,并在对患者进行随访时使用其特定测量单位。
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3个月
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肌酸激酶-心肌带 (IU/L)
大体时间:3个月
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该检查将作为数值记录在同一份问卷上,并在对患者进行随访时使用其特定测量单位。
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3个月
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C反应蛋白(毫克/升)
大体时间:3个月
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该检查将作为数值记录在同一份问卷上,并在对患者进行随访时使用其特定测量单位。
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3个月
|
合作者和调查者
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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