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SR34006

Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)

Ensayo de Sanofi en Atrial Fibrillation (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

4.673

previstos

Centros

84

Fin del objetivo primario

mar 2006

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2003.

Qué mide

Composite of all strokes and non-CNS systemic embolism. (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction. This obstruction may damage tissue. For example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore, patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as warfarin or acenocoumarol. The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol tablets. Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.

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Ficha completa en ClinicalTrials.gov (NCT00070655), actualizada en abr 2011.