AIM: A previous phase 2 study of patients undergoing non-urgent PCI treated withSCH530348 plus aspirin and clopidogrel tended to reduce MACE without increased bleeding. This study evaluated the safety of SCH530348 in Japanese patients with NSTE ACS. METHODS: Subjects (117), in whom PCI was planned, receivedstandard-of-care (aspirin, ticlopidine, and heparin) and were randomized 4:1 to receive either SCH530348 (20 or 40 mg loading dose followed by 1 mg/d or 2.5 mg/d for 60 days) or placebo. The key safety endpoint was TIMI major and minor bleeding in the PCI cohort (n=92). The key exploratory efficacy endpoint was MACE and death within 60 days. Addition of SCH530348 to standard-of-care did not significantly increase the rate of TIMI major and minor bleeding (or non-TIMI bleeding) in the primary cohort. RESULTS: Incidence (non-MACE) and discontinuation of AEs were similar across groups. PCI subjects treated with SCH530348 plus standard-of-care experienced a significant reduction in periprocedural MI compared with standard-of-care alone (16.9% vs 42.9%, respectively; p=0.013). There were no deaths or any other MACE. CONCLUSION:SCH530348 added to standard-of-care did not result in excess bleeding in Japanese subjects withNSTE ACS but significantly reduced the incidence of periprocedural MI in subjects undergoing urgent PCI.
RCT Entities:
AIM: A previous phase 2 study of patients undergoing non-urgent PCI treated with SCH530348 plus aspirin and clopidogrel tended to reduce MACE without increased bleeding. This study evaluated the safety of SCH530348 in Japanese patients with NSTE ACS. METHODS: Subjects (117), in whom PCI was planned, received standard-of-care (aspirin, ticlopidine, and heparin) and were randomized 4:1 to receive either SCH530348 (20 or 40 mg loading dose followed by 1 mg/d or 2.5 mg/d for 60 days) or placebo. The key safety endpoint was TIMI major and minor bleeding in the PCI cohort (n=92). The key exploratory efficacy endpoint was MACE and death within 60 days. Addition of SCH530348 to standard-of-care did not significantly increase the rate of TIMI major and minor bleeding (or non-TIMI bleeding) in the primary cohort. RESULTS: Incidence (non-MACE) and discontinuation of AEs were similar across groups. PCI subjects treated with SCH530348 plus standard-of-care experienced a significant reduction in periprocedural MI compared with standard-of-care alone (16.9% vs 42.9%, respectively; p=0.013). There were no deaths or any other MACE. CONCLUSION:SCH530348 added to standard-of-care did not result in excess bleeding in Japanese subjects with NSTE ACS but significantly reduced the incidence of periprocedural MI in subjects undergoing urgent PCI.
Authors: Teddy Kosoglou; Larisa Reyderman; Renger G Tiessen; André A van Vliet; Robert R Fales; Robert Keller; Bo Yang; David L Cutler Journal: Eur J Clin Pharmacol Date: 2011-09-21 Impact factor: 2.953
Authors: Teddy Kosoglou; Walter K Kraft; Bharath Kumar; Paul Statkevich; Fengjuan Xuan; Lei Ma; Lisa K Jennings; James E Schiller; Ronald B Langdon; David L Cutler Journal: Eur J Clin Pharmacol Date: 2012-02-08 Impact factor: 2.953