Health Condition 1: null- Subjects undergoing elective total knee or hip replacement or a revision of at least one component of a total knee or hip replacement.
Conditions
Interventions
Intervention1: Apixaban: Apixaban 2.5 mg will be the only investigational product in this study.
Dose : 2.5 mg BID
Route of Administration: Oral
Frequency of Dosing : Twice a day following total knee
Sponsors
Bristol Myers Squibb and Pfizer
Eligibility
Inclusion criteria
Inclusion criteria: 1) Signed Written Informed Consent a) Age >18 years b) Subjects must be willing and able to give written informed consent. Consent to participate in the study must be obtained prior to any screening procedures. 2) Target Population a) Subjects undergoing elective total knee or hip replacement or a revision of at least one component of a total knee or hip replacement. 3) Age and Reproductive Status a) Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. See Section 3.3.3 for the definition of WOCBP. b) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product. c) Women must not be breastfeeding d) Sexually active fertile men must use effective birth control if their partners are WOCBP.
Exclusion criteria
Exclusion criteria: 1) Target Disease Exceptions a) Known or suspected, acquired or bleeding or coagulation disorder in the subject or a first degree relative b) Known coagulopathy c) Active bleeding or at high risk for bleeding. 2) Medical History and Concurrent Diseases a) Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days b) Active hepatobiliary disease c) Alcohol and/or substance abuse within the past year d) Any condition, in the opinion of the Investigator, for which surgery or administration of an anticoagulant is contraindicated. 3) Physical and Laboratory Test Findings a) Two consecutive blood pressure readings within 15-30 minutes with supine SBP 180 mm Hg or supine DBP 105 mm Hg b) Hemoglobin 9 g/dL c) Platelet count 100,000/mm3 d) Creatinine clearance 30 mL/min as estimated by the method of Cockcroft and Gault e) Active hepatobiliary disease, based on an ALT or AST 2 x ULN or a Total Bilirubin ï?³ 1.5 x ULN (unless an alternative causative factor [eg, Gilbertâ??s syndrome] is identified. 4) Sex and Reproductive Status a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire treatment period of the study b) Women who are pregnant or breastfeeding c) Women with a positive pregnancy test on enrollment or prior to investigational product administration. 5) Other Exclusion Criteria a) Prisoners or subjects who are involuntarily incarcerated b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness c) Administration of any investigational drug currently or within 30 days prior to enrollment into this study. 6) Prohibited Treatments and/or Therapies a) Dual antiplatelet therapy (eg, aspirin and clopidogrel) b) Vitamin K antagonist or other novel oral anticoagulant (such as rivaroxaban or dabigatran) during the treatment period c) Ongoing unfractionated heparin or low molecular weight heparin use d) Use of thrombolytics within past 7 days e) Use of Fondaparinux.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to evaluate the safety of apixaban in prophylaxis of VTE in Indian patients undergoing elective total knee or hip replacementTimepoint: Till end of treatment and 2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include adjudicated DVT or PE and all cause deathTimepoint: will be assessed up to end of treatment and 2 days | — |
Countries
India
Contacts
Public ContactSubashri Shivkumar
Bristol Myers Squibb India Pvt. Ltd
Outcome results
None listed