Abstract
BackgroundThe 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).ObjectiveTo outline in detail the predetermined statistical analysis plan for the ‘alteplase dose arm’ of the study.MethodsAll 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.ResultsA 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.ConclusionsWe 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.
Highlights
The ENhanced Control of Hypertension And Thrombolysis strokE stuDy trial is a 2 × 2 quasi-factorial activecomparison, 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 has superior efficacy and lower risk of any intracerebral hemorrhage compared with guideline-recommended blood pressure control
We describe the statistical analysis plan (SAP) for the ENCHANTED ‘alteplase dose’ arm, where patient recruitment has been more rapid and the required sample size will be achieved sooner than for the blood pressure (BP) control arm. This SAP was completed prior to completion of the data collection, and is what investigators will adhere to in analyzing the results of the study pertaining to the dose of alteplase in acute ischemic stroke (AIS)
Special attention will need to be given to assessing the results of both the as-randomized, intent-to-treat, and per-protocol population analyses, and of any trade-offs that may arise between the potential benefits and harms of low-dose compared with standard-dose alteplase
Summary
The ENhanced Control of Hypertension And Thrombolysis strokE stuDy trial is a 2 × 2 quasi-factorial activecomparison, 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
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