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PR asugrel IN Comparison to C lopidogrel for I nhibition of PL atelet Activation and Aggr E gation (PRINCIPLE) – T

PR asugrel IN Comparison to C lopidogrel for I nhibition of PL atelet Activation and Aggr E gation (PRINCIPLE) – TIMI 44. Study Design. Loading Phase N=201 . Clopidogrel naïve No planned GP IIb/IIIa use. Planned Elective PCI Baseline Laboratory Measures. Clopidogrel 600 mg.

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PR asugrel IN Comparison to C lopidogrel for I nhibition of PL atelet Activation and Aggr E gation (PRINCIPLE) – T

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  1. PRasugrel IN Comparison to Clopidogrel for Inhibition of PLatelet Activation and AggrEgation (PRINCIPLE) – TIMI 44

  2. Study Design Loading Phase N=201 Clopidogrel naïve No planned GP IIb/IIIa use Planned Elective PCI Baseline Laboratory Measures Clopidogrel 600 mg Prasugrel 60 mg 0.5 h Post-Loading Dose Labs Coronary Angiography Post-Angiography Labs PCI No PCI Maintenance Phase N=100 6h* Labs, 18-24h Labs 6h* Labs, 15d Events Clopidogrel 150 mg x 14d Prasugrel 10 mg x 14d 15d Clinical Events, Labs,† CROSSOVER Prasugrel 10 mg x 14d Clopidogrel 150 mg x 14d 29d Clinical Events, Labs† 1º EPs: *Loading = 6h IPA (20 µM ADP); †Maintenance = 15d or 29d IPA (20 µM ADP) Wiviott SD et al, Circulation 2007 Copyright ©2007 American Heart Association

  3. PRIMARY EP Acute Phase: IPA 20 uM ADP P<0.0001 for each Prasugrel 60 mg IPA (%; 20 mM ADP) Hours Wiviott SD et al, Circulation 2007 Copyright ©2007 American Heart Association

  4. Maximal Platelet Aggregation (MPA) P<0.0001 for each MPA (%; 20 mM ADP) Prasugrel 60 mg Hours

  5. VASP Phosphorylation Ratio P<0.0001 for each VASP Phosphorylation Ratio Prasugrel 60 mg Hours

  6. PRIMARY EP Chronic Phase: IPA 20 uM ADP Difference Between Treatments: 14.9 [95% CI 10.6 – 19.3], P<0.0001 Prasugrel 10 mg Prasugrel 10 mg IPA (%; 20 mM ADP) Days

  7. Maximal Platelet Aggregation (MPA) Difference Between Treatments: 11.3 [95% CI 8.1 – 14.5], P<0.0001 Clopidogrel 150 mg Clopidogrel 150 mg MPA (%; 20 mM ADP) Prasugrel 10 mg Prasugrel 10 mg Days

  8. VASP Phosphorylation Ratio Difference Between Treatments: 20.1 [95% CI 14.5 – 25.7], P<0.0001 Clopidogrel 150 mg Clopidogrel 150 mg VASP Phosphorylation Ratio Prasugrel 10 mg Prasugrel 10 mg Days

  9. Thienopyridine Hyporesponsiveness: IPA 20 uM ADP < 20% P =0.0008 Clopidogrel Prasugrel P <0.0001 Percent of Subjects P =0.0005 P =0.0002 P =0.06 P =0.18 Hours

  10. Implications PRINCIPLE – TIMI 44 extends the pharmacologic superiority of the TRITON – TIMI 38 dose of prasugrel (60 mg/10 mg) to higher doses of clopidogrel (600 mg/150mg) in PCI. TRITON – TIMI 381tested hypothesis that an agent that with higher and more consistent IPA than standard approved clopidogrel (300 mg/ 75 mg) will improve clinical outcomes 1 Wiviott SD, Braunwald E, McCabe CH et al NEJM2007

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