Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery

Overview[ - collapse ][ - ]

Purpose 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
ConditionAnticoagulation
InterventionDrug: Apixaban
PhasePhase 4
SponsorBristol-Myers Squibb
Responsible PartyBristol-Myers Squibb
ClinicalTrials.gov IdentifierNCT01884337
First ReceivedJune 6, 2013
Last UpdatedOctober 7, 2013
Last verifiedOctober 2013

Tracking Information[ + expand ][ + ]

First Received DateJune 6, 2013
Last Updated DateOctober 7, 2013
Start DateDecember 2013
Estimated Primary Completion DateFebruary 2015
Current Primary Outcome MeasuresThe primary study endpoint is a composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding/clinically relevant non-major bleeding (CRNM) in subjects undergoing elective total knee or hip replacement [Time Frame: Up to End of Treatment+2 days (Up to Day 35+2 for THR subjects and up to Day 12+2 for TKR subjects)] [Designated as safety issue: Yes]ISTH major bleeding is;
Fatal or
Bleeding in a critical organ, such as brain, spine, eye, retroperitoneum, joint, heart sac, or skeletal muscle (and resulting in compartment syndrome), or
Bleeding that results in a fall of hemoglobin of 2 g/dL or more or transfusion of 2 units or more of packed red cells or whole blood within 24 hours
CRNM bleeding is;
Is clinically acute and overt
Does not satisfy criteria as a major bleed but requires medical intervention, such as a visit to a physician's office, emergency room, or urgent care center for epistaxis
THR = Total hip replacement
TKR = Total knee replacement
Current Secondary Outcome MeasuresComposite of VTE/all cause death, where VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism [Time Frame: Up to end of treatment+2 days (Up to Day 35+2 for THR subjects and up to Day 12+2 for TKR subjects)] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleMulti-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery
Official TitleA 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
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
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignEndpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionAnticoagulation
InterventionDrug: Apixaban
Other Names:
  • Eliquis
  • BMS-562247
Study Arm (s)Experimental: Apixaban (2.5 mg)
Apixaban 2.5 mg tablets by mouth twice daily, 12 days for TKR subjects or 35 days for THR subjects

Recruitment Information[ + expand ][ + ]

Recruitment StatusNot yet recruiting
Estimated Enrollment500
Estimated Completion DateFebruary 2015
Estimated Primary Completion DateFebruary 2015
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: For Site information please email:
Clinical.Trials@bms.com
Location CountriesIndia

Administrative Information[ + expand ][ + ]

NCT Number NCT01884337
Other Study ID NumbersCV185-158
Has Data Monitoring CommitteeNo
Information Provided ByBristol-Myers Squibb
Study SponsorBristol-Myers Squibb
CollaboratorsPfizer
Investigators Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Verification DateOctober 2013

Locations[ + expand ][ + ]

Local Institution
Ahmedabad, India, 380015
Contact: Site 0011
Not yet recruiting
Local Institution
Ahmedabad, India, 380054
Contact: Site 0049
Not yet recruiting
Local Institution
Ahmedabad, India, 380060
Contact: Site 0047
Not yet recruiting
Local Institution
Bangalore, India, 560054
Contact: Site 0013
Not yet recruiting
Local Institution
Bangalore, India, 560 034
Contact: Site 0057
Not yet recruiting
Local Institution
Bangalore, India, 560076
Contact: Site 0054
Not yet recruiting
Local Institution
Bangalore, India, 560076
Contact: Site 0024
Not yet recruiting
Local Institution
Belgaum, India, 590010
Contact: Site 0058
Not yet recruiting
Local Institution
Chandigarh, India, 160030
Contact: Site 0023
Not yet recruiting
Local Institution
Chandigarh, India, 160012
Contact: Site 0040
Not yet recruiting
Local Institution
Chennai, India, 600116
Contact: Site 0021
Not yet recruiting
Local Institution
Chennai, India, 6000006
Contact: Site 0053
Not yet recruiting
Local Institution
Hyderabad, India, 500082
Contact: Site 0043
Not yet recruiting
Local Institution
Hyderabad, India, 500096
Contact: Site 0010
Not yet recruiting
Local Institution
Hyderabad, India, 500001
Contact: Site 0055
Not yet recruiting
Local Institution
Kolkata, India, 700107
Contact: Site 0035
Not yet recruiting
Local Institution
Lucknow, India, 226003
Contact: Site 0026
Not yet recruiting
Local Institution
Ludhiana, India, 141001
Contact: Site 0030
Not yet recruiting
Local Institution
Mangalore, India, 575001
Contact: Site 0017
Not yet recruiting
Local Institution
Mohali, India, 160062
Contact: Site 0034
Not yet recruiting
Local Institution
Mumbai, India, 400026
Contact: Site 0001
Not yet recruiting
Local Institution
New Delhi, India, 110029
Contact: Site 0052
Not yet recruiting
Local Institution
Pune, India, 411044
Contact: Site 0016
Not yet recruiting
Local Institution
Pune, India, 411004
Contact: Site 0019
Not yet recruiting