The Clinical Trials of the European Cooperative Study for Recombinant Tissue-Type Plasminogen Activator (rt-PA)

  • Alfred E. R. Arnold
  • David de Bono
  • Jacobus Lubsen
  • Maarten L. Simoons
  • Frans Van de Werf
  • Marc Verstraete
Part of the Developments in Cardiovascular Medicine book series (DICM, volume 160)

Abstract

In Table 1 a historical review of the European Cooperative Study Group for rt-PA (ECSG) is listed. The benefit of thrombolytic therapy is conferred by reopening of occluded coronary arteries, leading to limitation of infarct size, preservation of left ventricular function and mortality reduction. Parallel to this pathophysiologic mechanism, the following outcome parameters were considered in the trials of the European Cooperative Study Group: early coronary patency, enzymatic infarct size and left ventricular function. A mortality trial, requiring thousands of patients, was considered unethical without any proof of efficacy of rt-PA in terms of coronary patency and infarct size limitation. Similarly, a trial measuring enzymatic infarct size and left ventricular ejection fraction, requiring several hundreds of patients could not be performed without proof of efficacy of rt-PA in terms of coronary patency. Assessment of the coronary recanalization rate required pre-treatment angiography, which would delay treatment and was therefore rejected. Furthennore, sequential assessment of patency at various times in one patient was omitted to avoid the effect of repeated contrast injections on coronary recanalization.

Keywords

Placebo Depression Ischemia Titration Aspirin 

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Copyright information

© Springer Science+Business Media New York 1994

Authors and Affiliations

  • Alfred E. R. Arnold
    • 1
  • David de Bono
    • 1
  • Jacobus Lubsen
    • 1
  • Maarten L. Simoons
    • 1
  • Frans Van de Werf
    • 1
  • Marc Verstraete
    • 1
  1. 1.Department of CardiologyMedical Center AlkmaarThe Netherlands

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