BACKGROUND Adjudication of endpoints is a standard procedure in cardiovascular clinical trials. However, several studies indicate that the benefit of adjudication in estimating treatment effect may be limited. AIMS This post hoc analysis of SOCRATES (NCT01994720) compared the treatment effects and investigated the agreement of clinical event assessment by site investigators and independent adjudicators. METHODS SOCRATES compared ticagrelor and aspirin in 13,199 patients with acute minor stroke or high-risk transient ischemic attack. The primary endpoint was stroke, myocardial infarction, or death. Stroke was the major component of the primary endpoint and a secondary endpoint. The endpoints were adjudicated by a blinded independent committee. We compared the treatment effect on the primary endpoint and stroke alone based on the investigators' and adjudicators' assessments, and investigated the agreement rate on the stroke endpoint and major hemorrhages. RESULTS The hazard ratios (95% confidence interval) for ticagrelor versus aspirin therapy for the primary endpoint were 0.89 (0.78-1.01) when calculated on adjudicator-assessed events and 0.88 (0.78-1.00) for investigator-assessed events. The hazard ratios (95% confidence intervals) for stroke were 0.86 (0.75-0.99) based on the adjudicators' diagnoses and 0.85 (0.75-0.97) based on the investigators' diagnoses. The overall agreement between adjudicator- and investigator-diagnosed stroke was 91%, and for major hemorrhages was 88%. CONCLUSIONS In SOCRATES, there was no clinically meaningful difference in the estimated treatment effect, on either the primary endpoint or stroke, by using investigator- or adjudicator-assessed events. Double-blind treatment outcome studies with stroke endpoints may not benefit from adjudication. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01994720.

中文翻译：

---

通过研究者评估的事件评估替卡格雷与阿司匹林的治疗效果，并与独立事件裁决委员会在SOCRATES试验中做出的判断进行比较。

背景技术终点的判定是心血管临床试验中的标准程序。但是，一些研究表明，在评估治疗效果方面，裁决的益处可能是有限的。目的SOCSOCS的事后分析（NCT01994720）比较了治疗效果，并调查了现场调查员和独立评审员进行的临床事件评估的协议。方法SOCRATES比较了ticagrelor和阿司匹林在13,199例急性轻度中风或高危短暂性脑缺血发作患者中的作用。主要终点为中风，心肌梗塞或死亡。中风是主要终点和次要终点的主要组成部分。端点由盲目的独立委员会裁定。根据研究者的研究，我们比较了仅对主要终点和中风的治疗效果 和评审员的评估，并调查了卒中终点和重大出血的同意率。结果当根据评审员评估的事件进行计算时，替卡格雷或阿司匹林治疗的主要终点风险比（95％置信区间）为0.89（0.78-1.01），对于研究者评估的事件为0.88（0.78-1.00）。根据评审员的诊断，中风的危险比（95％置信区间）为0.86（0.75-0.99），而根据调查员的诊断为0.85（0.75-0.97）。审判者和研究者诊断的中风之间的总体一致性为91％，严重出血的总体一致性为88％。结论SOCRATES对主要终点或卒中的估计治疗效果没有临床意义的差异，通过使用调查员或裁判员评估的事件。卒中终点的双盲治疗结果研究可能无法从裁决中受益。试验注册ClinicalTrials.gov标识符：NCT01994720。