- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00133250
Value of Abciximab in Patients With AMI Undergoing Primary PCI After Clopidogrel Pretreatment (BRAVE 3)
Value of Abciximab in Patients With AMI Undergoing PCI After High Dose Clopidogrel Pretreatment (BRAVE 3)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The goal of all reperfusion therapies in acute myocardial infarction (AMI) is an effective restoration of coronary blood flow and the reduction of infarct size. Recently, the researchers were able to achieve excellent results with primary stenting plus abciximab in terms of reduction of infarct size and improvement of clinical outcome in the STOPAMI trial. This strategy provided a clear benefit compared to fibrinolysis. On the basis of the data published in the last 2 years, hospitals without angioplasty facilities have now better possibilities to improve the results of primary treatment of patients with AMI by immediately referring these patients to highly experienced centers in coronary interventions. There is an increasing interest to assess the additional advantages of pharmacologic reperfusion approaches which are readily applicable in the time window between presentation and arrival at the catheterization room. Two studies have shown that the results of the PCI in patients with AMI pretreated with fibrinolysis may even be more unfavorable than those achieved with angioplasty alone. Glycoprotein (GP) IIb/IIIa blocker abciximab has been shown to improve the results of the primary PCI in AMI. However, no rapidly effective antiplatelets therapy was available at the time when the studies on the benefit of abciximab were performed. Recent studies have shown that a high, 600 mg loading dose of clopidogrel is significantly more rapidly acting and that maximal inhibition of platelet aggregation is achieved within 2 hours after administration. In the ISAR-REACT trial, a high loading dose of clopidogrel was well tolerated, associated with such a low frequency of procedural complications that the use of abciximab offered no clinically measurable benefit at 30 days.
Comparison:
Abciximab (bolus+infusion for 12h) versus Placebo (bolus+infusion for 12h) after pre-treatment with 600 mg clopidogrel.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Vienna, Austria, 1090
- Allgemeines Krankenhaus Wien
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Garmisch-Partenkirchen, Germania, 82467
- Klinikum Garmisch-Partenkirchen
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Munich, Germania, 80636
- Deutsches Herzzentrum Muenchen
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Munich, Germania, 81675
- First Medizinische Klinik, Klinikum rechts der Isar
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Traunstein, Germania, 83278
- Klinikum Traunstein
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients presenting with ST-Elevation acute myocardial infarction within 24 hours from the onset of symptoms
Exclusion Criteria:
- Age >80 years
- Malignancies
- Cardiogenic shock
- Prolonged cardio-pulmonary resuscitation
- Increased risk of bleeding
- Relevant hematologic deviations (hemoglobin <100 g/L or hematocrit <34%, platelet count <100 x 10^9 /L or platelet count >600 x 10^9 /L)
- Known allergy to the study medication
- Pregnancy (present or suspected)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: A
Abciximab
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Abciximab bolus and infusion is given.
Study medication includes 3 identical vials, each with 5 ml solution containing 10 mg abciximab.
The bolus dose to be given should be rated at 0.125 ml/kg of patient's weight.
After the bolus, a total dose of 0.045 ml/kg study substance (up to a maximal quantity of 3.6 ml) should be given over 12 hours.
Altri nomi:
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Comparatore placebo: B
Heparin Sodium
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Placebo bolus plus infusion is given.
Study medication includes 3 identical vials, each with 5 ml solution containing 3000 U Heparin.
The bolus dose to be given should be rated at 0.125 ml/kg of patient's weight.
After the bolus, a total dose of 0.045 ml/kg study substance (up to a maximal quantity of 3.6 ml) should be given over 12 hours.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Left ventricular infarct size calculated as the final perfusion defect at follow-up scintigraphic study
Lasso di tempo: 5-7 days
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5-7 days
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Clinical adverse events (death of any cause, reinfarction, stroke, urgent reinterventions, major and minor bleeding complications, thrombocytopenia <20 x 10^9 /L)
Lasso di tempo: 30 days
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30 days
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Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Pubblicazioni generali
- Muller I, Seyfarth M, Rudiger S, Wolf B, Pogatsa-Murray G, Schomig A, Gawaz M. Effect of a high loading dose of clopidogrel on platelet function in patients undergoing coronary stent placement. Heart. 2001 Jan;85(1):92-3. doi: 10.1136/heart.85.1.92. No abstract available.
- Kastrati A, Mehilli J, Schuhlen H, Dirschinger J, Dotzer F, ten Berg JM, Neumann FJ, Bollwein H, Volmer C, Gawaz M, Berger PB, Schomig A; Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Study Investigators. A clinical trial of abciximab in elective percutaneous coronary intervention after pretreatment with clopidogrel. N Engl J Med. 2004 Jan 15;350(3):232-8. doi: 10.1056/NEJMoa031859.
- Kastrati A, Mehilli J, Dirschinger J, Schricke U, Neverve J, Pache J, Martinoff S, Neumann FJ, Nekolla S, Blasini R, Seyfarth M, Schwaiger M, Schomig A; Stent versus Thrombolysis for Occluded Coronary Arteries in Patients With Acute Myocardial Infarction (STOPAMI-2) Study. Myocardial salvage after coronary stenting plus abciximab versus fibrinolysis plus abciximab in patients with acute myocardial infarction: a randomised trial. Lancet. 2002 Mar 16;359(9310):920-5. doi: 10.1016/S0140-6736(02)08022-4.
- Weaver WD, Simes RJ, Betriu A, Grines CL, Zijlstra F, Garcia E, Grinfeld L, Gibbons RJ, Ribeiro EE, DeWood MA, Ribichini F. Comparison of primary coronary angioplasty and intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review. JAMA. 1997 Dec 17;278(23):2093-8. Erratum In: JAMA 1998 Jun 17;279(23):1876.
- Vermeer F, Oude Ophuis AJ, vd Berg EJ, Brunninkhuis LG, Werter CJ, Boehmer AG, Lousberg AH, Dassen WR, Bar FW. Prospective randomised comparison between thrombolysis, rescue PTCA, and primary PTCA in patients with extensive myocardial infarction admitted to a hospital without PTCA facilities: a safety and feasibility study. Heart. 1999 Oct;82(4):426-31. doi: 10.1136/hrt.82.4.426.
- Neumann FJ, Blasini R, Schmitt C, Alt E, Dirschinger J, Gawaz M, Kastrati A, Schomig A. Effect of glycoprotein IIb/IIIa receptor blockade on recovery of coronary flow and left ventricular function after the placement of coronary-artery stents in acute myocardial infarction. Circulation. 1998 Dec 15;98(24):2695-701. doi: 10.1161/01.cir.98.24.2695.
- Kastrati A, Mehilli J, Schlotterbeck K, Dotzer F, Dirschinger J, Schmitt C, Nekolla SG, Seyfarth M, Martinoff S, Markwardt C, Clermont G, Gerbig HW, Leiss J, Schwaiger M, Schomig A; Bavarian Reperfusion Alternatives Evaluation (BRAVE) Study Investigators. Early administration of reteplase plus abciximab vs abciximab alone in patients with acute myocardial infarction referred for percutaneous coronary intervention: a randomized controlled trial. JAMA. 2004 Feb 25;291(8):947-54. doi: 10.1001/jama.291.8.947.
- Mehilli J, Kastrati A, Schulz S, Frungel S, Nekolla SG, Moshage W, Dotzer F, Huber K, Pache J, Dirschinger J, Seyfarth M, Martinoff S, Schwaiger M, Schomig A; Bavarian Reperfusion Alternatives Evaluation-3 (BRAVE-3) Study Investigators. Abciximab in patients with acute ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention after clopidogrel loading: a randomized double-blind trial. Circulation. 2009 Apr 14;119(14):1933-40. doi: 10.1161/CIRCULATIONAHA.108.818617. Epub 2009 Mar 30.
- Schulz S, Birkmeier KA, Ndrepepa G, Moshage W, Dotzer F, Huber K, Dirschinger J, Seyfarth M, Schomig A, Kastrati A, Mehilli J. One-year clinical outcomes with abciximab in acute myocardial infarction: results of the BRAVE-3 randomized trial. Clin Res Cardiol. 2010 Dec;99(12):795-802. doi: 10.1007/s00392-010-0185-z. Epub 2010 Jun 27.
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Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Ischemia
- Processi patologici
- Necrosi
- Ischemia miocardica
- Malattie cardiache
- Malattia cardiovascolare
- Malattie vascolari
- Infarto miocardico
- Infarto
- Meccanismi molecolari dell'azione farmacologica
- Agenti fibrinolitici
- Agenti modulanti la fibrina
- Inibitori dell'aggregazione piastrinica
- Anticoagulanti
- Eparina
- Eparina di calcio
- Abciximab
Altri numeri di identificazione dello studio
- GE IDE No. I00902
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Abciximab
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Centocor, Inc.Eli Lilly and CompanyCompletatoInfarto miocardicoStati Uniti, Francia, Regno Unito, Belgio, Germania, Spagna, Polonia, Bulgaria, Romania, Israele, Svezia, Canada, Repubblica Ceca, Argentina, Austria, Danimarca, Olanda, Sud Africa, Svizzera
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University of LeipzigCompletatoInfarto del miocardio con sopraslivellamento del tratto STGermania
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Laval UniversityEli Lilly and Company; Cordis Corporation; Quebec Heart InstituteCompletatoInfarto miocardico | IschemiaCanada
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University of PisaEli Lilly and CompanyCompletato
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Azienda Sanitaria OspedalieraCardiologia 2 - Emodinamica - Ospedale Maggiore, Novara, ItalyTerminatoInfarto miocardico | Malattia coronaricaItalia
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University Medical Center GroningenSconosciutoInfarto del miocardio con sopraslivellamento del tratto STOlanda
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Università degli Studi di FerraraCompletatoSindrome coronarica acutaItalia
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Aarhus University Hospital SkejbyDanish Heart FoundationCompletatoInfarto miocardico acutoDanimarca