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clopidogrel · CLEAN

Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned

Ensayo de Sanofi en Stable Angina · Myocardial Infarction (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

1.003

previstos

Centros

1

Fin del objetivo primario

ago 2010

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2008.

Qué mide

Time from randomization to first safety events of interest (12 Weeks (duble blind treatment period)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary objective: * To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interest in patients with stable angina (SA) or old myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being planned. Secondary objectives: * To compare the incidence of adverse events, adverse drug reactions and bleeding events in patients treated with clopidogrel versus ticlopidine. * To compare the incidence of major adverse cardiac events (MACE) and major adverse cardiac and cerebrovascular events (MACCE) in patients treated with clopidogrel versus ticlopidine. * To evaluate the long-term safety (adverse drug reactions, adverse events, safety events of interest and bleeding events) of clopidogrel for a total of 52 weeks; * To evaluate MACE and MACCE of clopidogrel for a total of 52 weeks.

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Ficha completa en ClinicalTrials.gov (NCT00821834), actualizada en jul 2011.