Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)
Condition: Deep Vein Thrombosis; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis
Intervention: Enoxaparin; Apixaban; Enoxaparin-matching placebo; Apixaban-matching placebo
Intervention description: Subcutaneous, 40 mg, once daily, 5 weeks; Oral tablets, 2.5 mg, twice daily, 5weeks; Administered as injection; Administered as oral tablets
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium; Apixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5407.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prevention of deep vein thrombosis and; pulmonary embolism after total hip replacement surgery

Summary:

      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
    

Eligibility criteria:

        Key Inclusion Criteria

          -  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

        Key Exclusion Criteria

          -  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

          -  Platelet count <100,000/mm^3

          -  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