Acute cardiac care & resuscitation

Danish-German cardiogenic shock trial—DanGer shock: Trial design update

Am Heart JPublished Statistical analysis plan of a randomised controlled trial

Authors' conclusion

Main analyses of the primary and secondary outcomes of the DanGer Shock trial will be conducted according to this publication.

Study context

Population
Patients with AMICS shock due to STEMI undergoing emergency PCI
Comparison
Impella CP vs no Impella CP
Primary endpoint
All-cause death (ITT population: all randomised consented patients)
Follow-up
180 days
Methodological detailsExploratory as-treated analysis of primary endpoint, No imputation of missing values, Secondary endpoints: composite of need for additional mechanical support, cardiac transplantation or all-cause death; days alive and out of hospital, Composite safety endpoint: major bleeding, vascular complications, device malfunction, aortic valve damage, significant hemolysis
  • Exploratory as-treated analysis of primary endpoint
  • No imputation of missing values
  • Secondary endpoints: composite of need for additional mechanical support, cardiac transplantation or all-cause death; days alive and out of hospital
  • Composite safety endpoint: major bleeding, vascular complications, device malfunction, aortic valve damage, significant hemolysis

Primary result

As reported in the abstract

  • No results reported; primary endpoint to be analysed by Cox proportional hazards, reported as HR with 95% CI
  • Intention to treat

Original publication

Danish-German cardiogenic shock trial—DanGer shock: Trial design update. Am Heart J. Published 19 October 2022. doi:10.1016/j.ahj.2022.10.078

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