A Multicenter, Randomized, Open-Label, Therapeutic, and Exploratory Trial to Evaluate the Tolerability and Efficacy of Platelet Glycoprotein IIb/IIIa Receptor Blocker (Clotinab(TM)) in High-Risk Patients with Percutaneous Coronary Intervention
Yonsei Medical Journal
; : 389-399, 2008.
Article
em En
| WPRIM
| ID: wpr-79515
Biblioteca responsável:
WPRO
ABSTRACT
PURPOSE:
This study was designed as a multicenter, randomized, open-label study to evaluate the efficacy and tolerability of Clotinab(TM). We expected to obtain same results as with ReoPro(R) in improving ischemic cardiac complications in high-risk patients who were about to undergo percutaneous coronary intervention (PCI). PATIENTS ANDMETHODS:
Patients of 19-80 years of age with acute coronary syndrome (ACS) who were about to undergo PCI were enrolled. After screening and confirmation of eligibility, patients were randomly assigned to different groups. Clotinab(TM) was given to 84 patients (58.7+/-10.6 years, MF=6816)and ReoPro(R)(59.0+/-10.5 years, MF=3010) was given to 40 patients before PCI. The primary efficacy endpoint was the onset of major adverse cardiac event (MACE) within 30 days from day 1. The tolerability endpoints were assessed based on bleeding, thrombocytopenia, change in Hb/Hct, human antichimetric antibody development, and adverse events.RESULTS:
The number of Clotinab(TM) patients experiencing MACE was 0 out of 76 per protocol (PP) patients. The MACE rate was 0%, and its 95% exact CI was [0.00-4.74%]. A major bleeding event developed in 3 patients in the ReoPro(R) group. The probability of MACE onset in Clotinab(TM) was estimated to be less than 5%. There was no clinically significant result in tolerability variables.CONCLUSION:
Clotinab(TM) is an effective and safe medicine in preventing ischemic cardiac complications for high-risk patients who will receive PCI.Palavras-chave
Texto completo:
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Base de dados:
WPRIM
Assunto principal:
Fragmentos Fab das Imunoglobulinas
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Inibidores da Agregação Plaquetária
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Angioplastia Coronária com Balão
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Drogas em Investigação
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Estudos Prospectivos
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Fatores de Risco
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Resultado do Tratamento
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Isquemia Miocárdica
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Complexo Glicoproteico GPIIb-IIIa de Plaquetas
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Síndrome Coronariana Aguda
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Guideline
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Observational_studies
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Risk_factors_studies
Limite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
Idioma:
En
Revista:
Yonsei Medical Journal
Ano de publicação:
2008
Tipo de documento:
Article