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Published byἩρακλῆς Βιτάλη Modified over 6 years ago
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Evaluating Recent Clinical Trial Data in the Secondary Prevention of ACS
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Disclosures
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The Good News! We now have simpler and perhaps safer oral anticoagulants
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Study Design Phase 2 Clinical Trials of New Anticoagulants Post-ACS
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Study Designs Largely similar but a few important differences
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ESTEEM – Ximelagatran, Bleeding
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ESTEEM – Ximelagatran, Efficacy
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Study Design
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ISTH Major or CRNM Bleeding
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Bleeding by Clopidogrel Status
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Ischemic Outcomes
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Ischemic Events by Clopidogrel Status
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Primary Safety Endpoint Clinically Significant Bleeding
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PRIMARY EFFICACY ENDPOINT Death / MI / Stroke / Severe Ischemia Requiring Revascularization
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SECONDARY EFFICACY ENDPOINT Death / MI / Stroke
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Primary Safety Endpoint Major and CRNM Bleeding at 6 Months
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Main Secondary Endpoint Composite of all cause mortality, non-fatal MI, non-fatal stroke, and severe recurrent ischemia at 6 months
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Phase 2 Conclusions
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Trial Stopped Prematurely
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Baseline Characteristics
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Index ACS Event
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Primary Outcome CV Death, MI, Ischemic Stroke
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Other Efficacy Outcomes
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Primary Outcome CV Death, MI, Stroke — Subgroups
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TIMI Major Bleeding
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TIMI Major Bleeding Subgroups
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Conclusions
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