Clinical Trials gov Identifier NCT 00133250 Abciximab in
Clinical. Trials. gov Identifier: NCT 00133250 Abciximab in Patients with AMI Undergoing Primary PCI After Clopidogrel Pretreatment BRAVE-3 Trial Bavarian Reperfusion Alternati. Ves 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 Ø Glycoprotein IIb/IIIa inhibitors (GPI) may improve the results of primary PCI in acute STEMI Ø Pretreatment with a 300 mg loading dose of clopidogrel improved the outcome of patients undergoing PCI in the setting of the CLARITY trial Ø A higher, 600 mg 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 (5 -7 days after randomization) Ø Final infarct size (% of the left ventricle) Myocardial perfusion % Secondary endpoints: Ø Ø Ø 0% 50% 100% 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 200 mg/day indefinitely Clopidogrel 2 x 75 mg/day for 3 days Clopidogrel 75 mg/day for at least 4 weeks
Reperfusion Strategy P =. 80 100 Drug-eluting stents % Bare metal stents PTCA 60 Medical treatment 20 Abciximab Placebo
Primary Endpoint Final infarct size Mean % LV P =. 47 Median 40 % LV [25 th; 75 th percentile] P =. 76 30 20 10 10 9 0 Abciximab Placebo
Cumulative Incidence 30 -Day Mortality 6 % P =. 53 4 Abciximab 2 Placebo 0 0 5 10 15 20 Days after randomization 25 30
Conclusion In patients with acute STEMI undergoing primary PCI after pre-treatment with a 600 mg loading dose of clopidogrel, the additional use of abciximab is not associated with further reduction in infarct size
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