A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The Advance-3 Study Apixaban Dosed Orally Versus Anticoagulation With Injectable Enoxaparin to Prevent Venous Thromboembolism)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00423319Tipo: INTERVENTIONALInicio: 1 de mar de 2007Fin estimado: 1 de sept de 2009

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients undergoing elective unilateral total hip replacement or a revision of at least 1 component of a total hip replacement.
Patients who were willing and able to undergo bilateral ascending contrast venography
Either sex, any race, 18 years and older

Criterios de exclusión

Platelet count \<100,000/mm\^3
Known or suspected bleeding or coagulation disorder in the patient or his or her first-degree relative
Known or suspected history of heparin-induced thrombocytopenia
Known coagulopathy
Active bleeding or at high risk for bleeding
Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
Active hepatobiliary disease
Alcohol and/or substance abuse within the past year
Any condition for which surgery or administration of an anticoagulant is contraindicated
Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure \>180 mm Hg or supine diastolic blood pressure \>105 mm Hg
Clinically significant laboratory abnormalities at the enrollment visit:
Hemoglobin \<10 g/dL
Creatinine clearance \<30 mL/min, as estimated by the method of Cockcroft and Gault
Alanine aminotransferase or aspartate aminotransferase \>2\*upper limit of normal or a total bilirubin ≥ 1.5\*1 (unless an alternative causative factor such as Gilbert's syndrome was identified)
Need for ongoing treatment with a parenteral or oral anticoagulant (eg, subjects with mechanical valves, warfarin eligible atrial fibrillation)
Current use of dextrans or fibrinolytics
Treatment with medications affecting coagulation or platelet function

Intervenciones

drug

Enoxaparin

Subcutaneous, 40 mg, once daily, 5 weeks

drug

Apixaban

Oral tablets, 2.5 mg, twice daily, 5weeks

drug

Enoxaparin-matching placebo

Administered as injection

drug

Apixaban-matching placebo

Administered as oral tablets

Ubicaciones

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution

Coronel Suárez, Buenos Aires, Argentina

Local Institution

Monte Grande, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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