Skip Navigation

European Heart Journal 2001 22(11):898-902; doi:10.1053/euhj.2000.2323
Copyright © 2001 by the European Society of Cardiology.
This Article
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (4)
Right arrowRequest Permissions
Google Scholar
Right arrow Articles by Lesaffre, E
Right arrow Articles by Van de Werf, F
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Lesaffre, E
Right arrow Articles by Van de Werf, F
Social Bookmarking
 Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

Clinical Trials

The general concepts of an equivalence trial, applied to ASSENT-2, a large-scale mortality study comparing two fibrinolytic agents in acute myocardial infarction

E Lesaffrea,f1, E Bluhmkib, F Wang-Clowc, S Beriolib, T Danaysb, N.L Foxc and F Van de Werfd

a Biostatistical Centre, University of Leuven, Belgium
b Boehringer Ingelheim Pharma KG, Ingelheim, Germany
c Genentech Inc. San Francisco, USA
d Department of Cardiology, University of Leuven, Belgium

Key Words: Alteplase, equivalence, mortality, myocardial infarction, non-inferiority, tenecteplase

f1 Correspondence: Emmanuel Lesaffre, Biostatistical Centre, U.Z. St. Rafael, Kapucijnenvoer 35, 3000 Leuven, Belgium.

References

  1. N Engl J Med. 1993;329:673–682[Abstract/Free Full Text]
  2. Lancet. 1999;354:716–722[CrossRef][ISI][Medline]
  3. N Engl J Med. 1997;337:1118–1123[Abstract/Free Full Text]
  4. Lancet. 1995;346:329–336[CrossRef][ISI][Medline]
  5. N Engl J Med. 1997;337:1124–1130[Abstract/Free Full Text]
  6. Tebbe U, Michels R, Adgey J, Boland J. Randomised, double-blind study comparing saruplase with streptokinase therapy in acute myocardial infarction: the COMPASS equivalence trial. J Am Coll Cardiol. 1998;31:487–493[Abstract/Free Full Text]
  7. Lancet. 1994;343:311–322[CrossRef][ISI][Medline]
  8. Koch, GG, Tangen, CM, Jung, JW, Amara, IA, Issues for covariance analysis of dichotomous and ordered categorical data from randomized clinical trials and nonparametric strategies for addressing them. Stat Med, 1998, 17, 1863, 92
  9. White H. Thrombolytic therapy and equivalence trials. J Am Coll Cardiol. 1998;31:494–496[Free Full Text]
  10. Califf RM. A perspective on the regulation of the evaluation of new antithrombotic drugs. Am J Cardiol. 1998;82:25–35[CrossRef]
  11. Hampton JR. The concept of equivalence and its application to the assessment of thrombolytic effects. Eur Heart J. 1997;18:22–27
  12. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence; the importance of rigorous methods. Br Med J. 1996;313:36–39[Free Full Text]
  13. Fleming TR. Evaluation of Active Control Trials in AIDS. J Immune Defic Synd. 1990;3:S82–S87
  14. Koch, GG, Gansky, SA, Statistical considerations for multiplicity in confirmatory protocols, Newport Beach, CA

Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?



This Article
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (4)
Right arrowRequest Permissions
Google Scholar
Right arrow Articles by Lesaffre, E
Right arrow Articles by Van de Werf, F
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Lesaffre, E
Right arrow Articles by Van de Werf, F
Social Bookmarking
 Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?