Clinical trial NCT01884337: Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery
Official title: A Phase IV, Open-Label, Multi-center Study to Evaluate the Safety of Apixaban in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anticoagulation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2013-06-24
Enrollment: 557
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this protocol is to evaluate the safety of Apixaban in prophylaxis of Venous Thromboembolism (VTE) in Indian patients undergoing elective total knee or hip replacement


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Subjects undergoing elective total knee or hip replacement or a revision of at least one component of a total knee or hip replacement

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Known or suspected, acquired or bleeding or coagulation disorder in the subject or a first degree relative
* Active bleeding or at high risk for bleeding.
* Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days other than the elective knee/hip surgery
* Active hepatobiliary disease
* Hemoglobin \<9 g/dL
* Platelet count \<100,000/mm3
* Creatinine clearance \<30 mL/min

Primary outcomes:
measure: Number of Participants With Composite of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding/Clinically Relevant Non-major Bleeding (CRNM) While Undergoing Elective TKR or THR at the End of Treatment + 2 Days
timeFrame: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR
Secondary outcomes:
measure: Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days
timeFrame: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR
Other outcomes:
Locations:
city: Kozhikode
country: India
facility: Local Institution
state: Kerala
city: Ahmedabad
country: India
facility: Local Institution
city: Ahmedabad
country: India
facility: Local Institution
city: Ahmedabad
country: India
facility: Local Institution
city: Alappuzha
country: India
facility: Local Institution
city: Aurangabad
country: India
facility: Local Institution
city: Bangalore
country: India
facility: Local Institution
city: Chandigarh
country: India
facility: Local Institution
city: Chennai
country: India
facility: Local Institution
city: Delhi
country: India
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
city: Kerala
country: India
facility: Local Institution
city: Lucknow
country: India
facility: Local Institution
city: Mohali
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: Nagpur
country: India
facility: Local Institution
city: Pune
country: India
facility: Local Institution
city: Pune
country: India
facility: Local Institution
city: Pune
country: India
facility: Local Institution
city: Pune
country: India
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: