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

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Presentation on theme: "Disclosures. Evaluating Recent Clinical Trial Data in the Secondary Prevention of ACS."— Presentation transcript:

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

2 Disclosures

3

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

5 Study Design Phase 2 Clinical Trials of New Anticoagulants Post-ACS

6 Study Designs Largely similar but a few important differences

7 ESTEEM – Ximelagatran, Bleeding

8 ESTEEM – Ximelagatran, Efficacy

9 Study Design

10 ISTH Major or CRNM Bleeding

11 Bleeding by Clopidogrel Status

12 Ischemic Outcomes

13 Ischemic Events by Clopidogrel Status

14 Primary Safety Endpoint Clinically Significant Bleeding

15

16 PRIMARY EFFICACY ENDPOINT Death / MI / Stroke / Severe Ischemia Requiring Revascularization

17 SECONDARY EFFICACY ENDPOINT Death / MI / Stroke

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20 Primary Safety Endpoint Major and CRNM Bleeding at 6 Months

21 Main Secondary Endpoint Composite of all cause mortality, non-fatal MI, non-fatal stroke, and severe recurrent ischemia at 6 months

22 Phase 2 Conclusions

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26 Trial Stopped Prematurely

27 Baseline Characteristics

28 Index ACS Event

29 Primary Outcome CV Death, MI, Ischemic Stroke

30 Other Efficacy Outcomes

31 Primary Outcome CV Death, MI, Stroke — Subgroups

32 TIMI Major Bleeding

33 TIMI Major Bleeding Subgroups

34 Conclusions

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