LIMIT AMI研究PPT课件.ppt

《LIMIT AMI研究PPT课件.ppt》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、KennethW.BaranMDfortheLIMITAMIInvestigatorsSt.PaulHeartClinic,St.Paul,MN,USASponsor:GenentechInc.,SouthSanFrancisco,USALIMITAMI(LImitationofMyocardialInjuryfollowingThrombolysisinAcuteMyocardialInfarction)Anangiographicsafetyandefficacytrialofanovelanti-CD18therapyinacutemyocardial

2、infarctioninconjunctionwiththrombolysisBaranKWAugust28,2000rhuMAbCD18Antibodyfragment[F(ab’)2]SingledoseadministeredasIVbolusPlasmahalf-life7to10hours90%CD18-containingreceptorsaturationmaintainedfor~24hours(0.5mg/kg)and~48hours(2.0mg/kg)BaranKWAugust28,2000TheLIMITAMITrialofrhuMA

3、bCD18STelevation>2leadsSymptoms<12hrsNopriorcoronarysurgeryNocardiogenicshockNothrombolyticexclusionsNomajorimmune-relatedrisksScreeningTheLIMITAMITrialofrhuMAbCD18STelevation>2leadsSymptoms<12hrsNopriorcoronarysurgeryNocardiogenicshockNothrombolyticexclusionsNomajorimmune-relatedr

4、isksScreeningRandomization1:1:1withadministrationpriortofull-dosetPA2mg/kg0.5mg/kgPlacebo+usualcareincludingaspirin,IVheparinTheLIMITAMITrialofrhuMAbCD18STelevation>2leadsSymptoms<12hrsNopriorcoronarysurgeryNocardiogenicshockNothrombolyticexclusionsNomajorimmune-relatedrisksScreeni

5、ngCoronaryangiography90minutesfromtPAinitiationRandomization1:1:1tostudydrugorplacebothenfull-dosetPA2mg/kg0.5mg/kgPlaceboCorrectedTIMIFrameCount,TIMIFlowGradeTIMIMyocardialPerfusionGradeAngioplasty±GpIIb/IIIainhibitorsasrequired+usualcareincludingaspirin,IVheparinTheLIMITAMITrialo

6、frhuMAbCD18Infarctsizesestamibiatrest,day6-9CKMB0-72hoursECGSTsegmentresolution180minutesFeverAntibioticuseGeneralSafetyOtherendpointsStatisticalAnalysisEfficacyendpointdataanalyzedbyindependentandblindedCoreLaboratoriesTimewindowswereusedforefficacyendpointsusingimputationformissi

7、ngdatawherepossible“Astreated”analysisoftheevaluablecohortSensitivityanalysespvalues:nonparametrictestsBaranKWAugust28,2000ResultsEnrollmentfromSeptember1998toMarch2000413subjectsrandomized394treatedwithrhuMAbCD18orplacebo19randomizedbutnottreatedmainlyduetoreviewofexclusioncriteri

8、a60centersinUSandCanadaBar