对心脏动患者心血管风险降低的密集血压控制随机对照试验的统计分析计划
Cerebrovascular diseases (Basel, Switzerland)
|September 2, 2025
概括
与标准对照组 (< 135 mmHg) 相比,心血管动患者的密集血压控制 (< 120 mmHg) 是否降低了心血管风险. 这项研究通过预先定义的统计计划确保了透明的分析.
科学领域:
- 心脏病学
- 临床试验
- 高血压管理
背景情况:
- 血压升高是心血管并发症的重要危险因素.
- 目前的指导方针建议适度的血压目标,但AF患者的最佳血压目标仍然不清楚.
- 在心房的心血管风险降低试验 (CRAFT) 解决了这一不确定性.
研究的目的:
- 评估家庭密集的静脉压控制 (<120 mmHg) 是否比标准的静脉压控制 (<135 mmHg) 更有效地减少AF患者的主要心血管事件.
- 在高危人群中比较两种不同的血压管理策略的有效性.
主要方法:
- 一个多中心的,前性的,随机的,开放的,盲目的终点试验设计.
- 招募1675名参与者以达到80%的检测能力,获胜率为1.50.
- 主要结局:心血管死亡,中风,心肌梗塞和心力衰竭住院的等级组合.
主要成果:
- 主要结果分析将使用胜利比率方法.
- 将使用Cox比例危险和Poisson回归来分析次要结果.
- 敏感性分析和缺失数据处理策略是事先规定的.
结论:
- 预先定义的统计分析计划 (SAP) 确保了CRAFT试验结果的透明度和可验证性.
- 为了保持内部有效性并最大限度地减少偏差,SAP以前性,独立于治疗分配的方式完成.
- 这种严格的方法旨在提供关于AF最佳BP管理的可靠证据.
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