The impact of postrandomization crossover of therapy in acute coronary syndromes care Academic Article uri icon

Overview

MeSH Major

  • Acute Coronary Syndrome
  • Anticoagulants
  • Enoxaparin
  • Heparin

abstract

  • Postrandomization events in clinical trials are accompanied by substantial confounders that require careful consideration. In SYNERGY, postrandomization crossovers occurred in nearly 10% of patients, abetted by the open-label trial design. These patients had increased incidence of bleeding and death/MI, but after adjustment using several modeling techniques, only a modest impact of postrandomization crossovers on treatment effect was observed. The usual methods of analyzing end points cannot adequately address biases in changing treatment in these patients. The potential biases of membership in a postrandomization subgroup, as well as the methods used to account for the biases, should be considered when weighing the strength of results. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00043784.

publication date

  • March 2011

Research

keywords

  • Academic Article

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.1161/CIRCOUTCOMES.109.853598

PubMed ID

  • 21304094

Additional Document Info

start page

  • 211

end page

  • 9

volume

  • 4

number

  • 2