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									  ClinicalTrials.gov Identifier: NCT00133250


Abciximab in Patients with AMI
Undergoing Primary PCI After
  Clopidogrel Pretreatment
                    BRAVE-3 Trial
   Bavarian Reperfusion AlternatiVes Evaluation-3 Trial


 J. Mehilli, A. Kastrati, K. Huber, S. Schulz, J. Pache,
 C.Markwardt, S. Kufner, F. Dotzer, K. Schlotterbeck,
               J. Dirschinger, A. Schömig .
               Background



 Glycoprotein IIb/IIIa inhibitors (GPI) may improve
  the results of primary PCI in acute STEMI
 Pretreatment with a 300mg loading dose of
  clopidogrel improved the outcome of patients
  undergoing PCI in the setting of the CLARITY trial
 A higher, 600mg loading dose of clopidogrel
  further enhances and accelerates platelet
  inhibition
             Objective


   ..to assess whether abciximab further
  reduces the infarct size in patients with
 acute ST-elevation myocardial infarction
undergoing PCI after pretreatment with 600
               mg clopidogrel
                    Endpoints

Primary endpoint:
                                                                  SPECT study
  Final infarct size
                                                                   (5-7 days after
  (% of the left ventricle)                                         randomization)
                                      Myocardial perfusion %


                                 0%            50%             100%
Secondary endpoints:

    Death
    Myocardial reinfarction
    Urgent revascularization
    Stroke
    Major and minor bleedings (TIMI criteria)
    Profound thrombocytopenia
           Study Therapy
(randomized, double-blind, multicenter)

           Clopidogrel 600 mg oral
          Aspirin 500 mg i.v. or oral
        Unfractionated Heparin 5000 IE



 Abciximab                      Placebo
    n=401                         n=399


         Aspirin 200mg/day indefinitely
      Clopidogrel 2 x 75mg/day for 3 days
   Clopidogrel 75mg/day for at least 4 weeks
        Reperfusion Strategy

              P =.80
100
                                 Drug-eluting stents
%
         44              44      Bare metal stents

                                 PTCA
 60
                                 Medical treatment

         48              50
 20
          4              3
          4              3
      Abciximab        Placebo
                    Primary Endpoint


          Final infarct size               Final infarct size
                  Mean                   Median   [25th; 75th percentile]
  40                                40
                 P = .47                            P =.76
% LV                              % LV
  30                                30


  20      15.7             16.6     20


  10                                10            10                 9

   0                                 0
       Abciximab Placebo                 Abciximab          Placebo
                               30-Day Mortality


                       6                 P = .53
Cumulative Incidence




                       %

                       4
                                                              Abciximab

                       2                                      Placebo

                       0
                           0   5    10         15       20    25        30
                                   Days after randomization
             Conclusion



    In patients with acute STEMI undergoing
 primary PCI after pre-treatment with a 600mg
loading dose of clopidogrel, the additional use
   of abciximab is not associated with further
             reduction in infarct size

								
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