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LIMIT AMI研究课件
rhuMAb CD18 Antibody fragment [F(ab’)2] Single dose administered as IV bolus Plasma half-life 7 to 10 hours ? 90% CD18-containing receptor saturation maintained for ~ 24 hours (0.5 mg/kg) and ~ 48 hours (2.0 mg/kg) Statistical Analysis Efficacy endpoint data analyzed by independent and blinded Core Laboratories Time windows were used for efficacy endpoints using imputation for missing data where possible “As treated” analysis of the evaluable cohort Sensitivity analyses p values: non parametric tests Results Enrollment from September 1998 to March 2000 413 subjects randomized 394 treated with rhuMAb CD18 or placebo 19 randomized but not treated mainly due to review of exclusion criteria 60 centers in US and Canada Baseline characteristics Concomitant Interventions Change in peripheral venous blood white cell counts - mean values Primary Endpoint: Corrected TIMI Frame Count @90 minutes % TIMI Grade 3 flow TIMI Flow Grades (all grades) TIMI Myocardial Perfusion Grade ECG ST segment elevation resolutionat 180 minutes Infarct Size by sestamibi scan Day 6-9 Clinical outcomes at Day 30 Safety - fever and antibiotic use Safety - Likely bacterial infections General Safety No effect on fibrinogen or d-dimer levels No increase in “serious and life-threatening bleeding” Slight trend towards increases in overall bleeding adverse events (? 10%) and transfusions (? 20%) Small number of mild thrombocytopenia cases 100,000/mm3: placebo 2 cases, 0.5 mg/kg 1 case, 2.0 mg/kg 5 cases No specific anti-rhuMAb CD18 antibody formation* Conclusions Baran KW August 28, 2000 Kenneth W. Baran MD for the LIMIT AMI Investigators St. Paul Heart Clinic, St. Paul, MN, USA Sponsor: Genentech Inc., South San Francisco, USA LIMIT AMI (LImitation of Myocardial Injury following Thrombolysis in Acute Myocardial Infarction) An angiographic safety and efficacy trial of a novel anti-CD18 therapy in acute myocardial infarction in conjunction with thrombolysis The LIMIT AMI Trial of rhuMAb CD1
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