A Phase IV, Open-Label, Multi-center Study to Evaluate the Safety of Apixaban in IndianSubjects Undergoing Elective Total Knee Replacement or Total Hip Replacement SurgeryThe purpose of the study is to gain experience with Apixaban in Indian patients undergoing orthopedic surgery
- Conditions
- Health Condition 1: null- Subjects undergoing elective total knee or hip replacement or a revision of at least onecomponent of a total knee or hip replacement.
- Registration Number
- CTRI/2015/03/005598
- Lead Sponsor
- Bristol Myers Squibb and Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 500
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the study is to evaluate the safety of apixaban in prophylaxis of VTE <br/ ><br>in Indian patients undergoing elective total knee or hip replacementTimepoint: Till end of treatment and 2 days
- Secondary Outcome Measures
Name Time Method Secondary endpoints include adjudicated DVT or PE and all cause deathTimepoint: will be assessed up to end of treatment and 2 days