ArticleAnnals of translational medicine2020
Statistical analysis plan for aggressive hydraTion in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) study.
Article in Annals of translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02067195 (Aggressive Hydration in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention to Prevent Contrast-Induced Nephropathy, A Randomized, Controlled Trial REduction of riSk of Contrast-Induced Nephropathy followINg carDiac Catheterization 1), which is not on this map. Not yet cited in PubMed.
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Aggressive Hydration in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention to Prevent Contrast-Induced Nephropathy, A Randomized, Controlled Trial REduction of riSk of Contrast-Induced Nephropathy followINg carDiac Catheterization 1
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Abstract
backgroundThe ATTEMPT study is a multicenter, randomized controlled trial which is investigator-based and open label in nature. For the study, 560 patients with ST-segment elevation myocardial infarction (STEMI) underwent primary percutaneous coronary intervention (pPCI) have been randomized (1:1) for treatment with periprocedural aggressive hydration (treatment group) or general hydration (control group). To improve the quality of the study's analysis and to minimize analysis bias based on the study's findings.
methodsThe design of the statistical analysis plan (SAP) was created by chief investigators and statisticians and received permission from the aggressive hydraTion in patients with ST-Elevation Myocardial infarction undergoing Primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) management committee. Treatment allocation and research data were reviewed by the Data Safety and Monitoring Committee and researchers were kept blind. We produced data shells based on a pre-existing published protocol and produced detailed descriptions of statistical analyses. This study includes primary, secondary and safety endpoints. Relevant statistical comparisons were planned and discussed in a transparent manner. They are publicly available, verifiable and were determined prior to the data collection process being completed.
resultsWe developed a SAP for the ATTEMPT study and an outline and list of mock tables were also created. We produced descriptions of analyses of baseline characteristics, patient care approaches, efficacy measures, and outcomes. This study defined five previously specified subgroups and compared the statistics of groups within these subgroups.
conclusionsThis SAP has been developed for the ATTEMPT study and has high-quality standards of internal validity to minimize analysis bias.
trial registrationClinicalTrials.gov number, NCT02067195.
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