1 / 36

Evaluating Recent Clinical Trial Data in the Secondary Prevention of ACS

Evaluating Recent Clinical Trial Data in the Secondary Prevention of ACS. Disclosures. The Good News! We now have simpler and perhaps safer oral anticoagulants. Study Design Phase 2 Clinical Trials of New Anticoagulants Post-ACS. Study Designs Largely similar but a few important differences.

ina-carey
Download Presentation

Evaluating Recent Clinical Trial Data in the Secondary Prevention of ACS

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Evaluating Recent Clinical Trial Data in the Secondary Prevention of ACS

  2. Disclosures

  3. The Good News!We now have simpler and perhaps safer oral anticoagulants

  4. Study DesignPhase 2 Clinical Trials of New Anticoagulants Post-ACS

  5. Study DesignsLargely similar but a few important differences

  6. ESTEEM – Ximelagatran, Bleeding

  7. ESTEEM – Ximelagatran, Efficacy

  8. Study Design

  9. ISTH Major or CRNM Bleeding

  10. Bleeding by Clopidogrel Status

  11. Ischemic Outcomes

  12. Ischemic Events by Clopidogrel Status

  13. Primary Safety EndpointClinically Significant Bleeding

  14. PRIMARY EFFICACY ENDPOINT Death / MI / Stroke / Severe Ischemia Requiring Revascularization

  15. SECONDARY EFFICACY ENDPOINT Death / MI / Stroke

  16. Primary Safety Endpoint Major and CRNM Bleeding at 6 Months

  17. Main Secondary EndpointComposite of all cause mortality, non-fatal MI, non-fatal stroke, and severe recurrent ischemia at 6 months

  18. Phase 2 Conclusions

  19. Trial Stopped Prematurely

  20. Baseline Characteristics

  21. Index ACS Event

  22. Primary OutcomeCV Death, MI, Ischemic Stroke

  23. Other Efficacy Outcomes

  24. Primary OutcomeCV Death, MI, Stroke — Subgroups

  25. TIMI Major Bleeding

  26. TIMI Major BleedingSubgroups

  27. Conclusions

More Related