Background

EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND) is a randomized, multicenter, double-blinded, placebo-controlled phase 3 trial to test the hypothesis of extending the thrombolysis time window to 9 h from stroke onset and in wake-up stroke (WUS) patients.

Objective

To formulate the detailed statistical analysis plan for the EXTEND trial prior to database lock. This statistical analysis plan is based on the published and registered EXTEND trial protocol and is developed by the blinded steering committee and management team.

Results

The developed EXTEND statistical analysis plan is transparent, verifiable, and predetermined before the database lock. It is consistent with reporting standards for clinical trials and provides for clear and open reporting.

Conclusions

Publication of a statistical analysis plan serves to reduce potential trial analysis and reporting bias and outlines pre-specified analyses to quantify the benefits and harms of extending the thrombolysis time window to 9 h from stroke onset and in wake-up stroke patients.

Trial registration: ClinicalTrials.gov number NCT00887328 registered 23/Apr/2009 and NCT01580839 (EXTEND International) registered 19/Apr/2012

中文翻译：

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延长紧急神经系统疾病（EXTEND）试验中溶栓时间的统计分析计划

背景

延长紧急神经系统疾病溶栓治疗的时间（EXTEND）是一项随机，多中心，双盲，安慰剂对照的3期临床试验，以检验将溶栓时间窗从中风发作和唤醒中风延长至9小时的假说（WUS）患者。

目的

为了在数据库锁定之前为EXTEND试验制定详细的统计分析计划。此统计分析计划基于已公开并注册的EXTEND试验方案，由盲目指导委员会和管理团队制定。

结果

所开发的EXTEND统计分析计划在数据库锁定之前是透明的，可验证的和预先确定的。它符合临床试验的报告标准，并提供清晰公开的报告。

结论

统计分析计划的发布有助于减少潜在的试验分析和报告偏倚，并概述了预先指定的分析，以量化将溶栓时间窗从中风发作和唤醒中风患者延长至9小时的利弊。

试验注册：ClinicalTrials.gov号NCT00887328注册于2009年4月23日，NCT01580839（EXTEND International）注册于19年4月19日