Statistical analysis plan for evaluating low- vs. Standard-dose alteplase in the ENhanced Control of Hypertension and Thrombolysis strokE stuDy (ENCHANTED)

Craig S. Anderson, Mark Woodward, Hisatomi Arima, Xiaoying Chen, Richard I. Lindley, Xia Wang, John Chalmers, Enchanted Investigators

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Background: The ENhanced Control of Hypertension And Thrombolysis strokE stuDy trial is a 2 × 2 quasi-factorial active-comparison, prospective, randomized, open, blinded endpoint clinical trial that is evaluating in thrombolysis-eligible acute ischemic stroke patients whether: (1) low-dose (0·6 mg/kg body weight) intravenous alteplase has noninferior efficacy and lower risk of symptomatic intracerebral hemorrhage compared with standard-dose (0·9 mg/kg body weight) intravenous alteplase; and (2) early intensive blood pressure lowering (systolic target 130-140 mmHg) has superior efficacy and lower risk of any intracerebral hemorrhage compared with guideline-recommended blood pressure control (systolic target <180 mmHg).Objective: To outline in detail the predetermined statistical analysis plan for the 'alteplase dose arm' of the study.Methods: All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be classified, and for each item, appropriate descriptive statistical analyses are planned with appropriate comparisons made between randomized groups. For the trial outcomes, the most appropriate statistical comparisons to be made between groups are planned and described.Results: A statistical analysis plan was developed for the results of the alteplase dose arm of the study that is transparent, available to the public, verifiable, and predetermined before completion of data collection.Conclusions: We have developed a predetermined statistical analysis plan for the ENhanced Control of Hypertension And Thrombolysis strokE stuDy alteplase dose arm which is to be followed to avoid analysis bias arising from prior knowledge of the study findings.

Original languageEnglish
Pages (from-to)1313-1315
Number of pages3
JournalInternational Journal of Stroke
Volume10
Issue number8
DOIs
Publication statusPublished - 1 Dec 2015
Externally publishedYes

Bibliographical note

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and
distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made

Keywords

  • acute
  • alteplase
  • clinical trials
  • statistical analysis plan
  • stroke
  • thrombolysis

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