The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism

CompletadoFase 3ClinicalTrials.gov

ID: NCT00062803Tipo: INTERVENTIONALInicio: 1 de jun de 2003Fin estimado: 1 de oct de 2005

Traducción no disponible, mostrando original

Resumen

Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Confirmed acute symptomatic Pulmonary Embolism (PE) with or without concomitant Deep Vein Thrombosis (DVT)
Written informed consent

Criterios de exclusión

Legal lower age limitations (country specific)
Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
Other indication for VKA than PE/DVT
More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW)heparin or initiation of VKA treatment prior to randomization
Participation in another pharmacotherapeutic study within the prior 30 days
Creatinine clearance \<10 mL/min, severe hepatic disease, or bacterial endocarditis
Life expectancy \<3 months
Active bleeding or high risk for bleeding
Uncontrolled hypertension: systolic blood pressure \>180 mm Hg or diastolic blood pressure \>110 mm Hg
Pregnancy or childbearing potential without proper contraceptive measures or women who are breastfeeding
Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin, enoxaparin, or tinzaparin

Intervenciones

drug

SR34006

drug

(LMW)heparin

drug

Warfarin VKA

drug

Acenocoumarol VKA

Ubicaciones

Buenos Aires, Argentina

Patrocinadores

PrincipalSanofi

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