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NICE-3 National Investigators Collaborating on Enoxaparin

NICE-3 Objectives. To assess the safety profile (primarily with respect to bleeding) of enoxaparin and a IIb/IIIa antagonist (abciximab, eptifibatide or tirofiban) in patients with ACSTo assess the feasibility and safety of bringing patients to the cath laboratory on combination therapy (without t

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NICE-3 National Investigators Collaborating on Enoxaparin

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    1. NICE-3 National Investigators Collaborating on Enoxaparin XXIInd Congress of the European Society of Cardiology August 30, 2000 Amsterdam, The Netherlands

    2. NICE-3 Objectives To assess the safety profile (primarily with respect to bleeding) of enoxaparin and a IIb/IIIa antagonist (abciximab, eptifibatide or tirofiban) in patients with ACS To assess the feasibility and safety of bringing patients to the cath laboratory on combination therapy (without the use of UFH)

    3. NICE-3 Inclusion Criteria Recent (w/in 24 hours) unprovoked or rest angina Documented ischemic CAD ECG changes Abnormal biomarkers Previously documented CAD Patients on prior UFH could be included

    4. NICE-3 Exclusion Criteria Evolving Q-wave MI Fibrinolytic Rx w/in 48 hours Cardiogenic shock Left main disease Valvular disease CABG w/in 2 mos.; revasc w/in 1 week Thrombocytopenia

    5. NICE-3 Protocol

    6. NICE-3 Protocol Primary Endpoint Non-CABG major bleeding (TIMI criteria) during hospitalization Secondary Endpoints Minor bleeding (TIMI criteria) Clinical efficacy Composite of death, MI, ischemia-driven TVR

    7. NICE-3 Sample Size Primary Hypothesis The 95% CI for major bleeding will not exceed the historical rate Agents examined as a whole and separately Example (Assuming major bleed rate of 2%): A 200 patient sample size has a 95% CI of approx 0.1-3.9% A 150 patient sample size has a 95% CI of approx 0-4.2%

    8. NICE-3 Demographics

    9. NICE-3 Bleeding (%)

    10. NICE-3 In-Hospital Clinical Outcomes (%)

    11. NICE-3 ?30% ? in Platelet Count

    12. NICE-3 All Major Bleeding (%)

    13. NICE-3 PCI Patients (n=292)

    14. NICE-3 Conclusions Combination of enoxaparin and IIb/IIIa Does not result in excess major bleeding Events (non-CABG) Patients on combination Rx can safely undergo PCI Clinical outcomes in NICE-3 were comparable to those noted in prior studies Therefore, not necessary to use UFH in: UA/NSTEMI patients undergoing coronary intervention who are treated with enoxaparin and an IV IIb/IIIa antagonist

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