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

Anticoagulation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884337
• Other study ID #: CV185-158
• Status: Completed
• Phase: Phase 4
• Start date: March 24, 2015
• Est. completion date: June 4, 2018

Study information

• Verified date: November 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 557
• Est. completion date: June 4, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulation

Intervention

Drug:
• Apixaban

Locations

Country	Name	City	State
India	Local Institution	Ahmedabad
India	Local Institution	Ahmedabad
India	Local Institution	Ahmedabad
India	Local Institution	Alappuzha
India	Local Institution	Aurangabad
India	Local Institution	Bangalore
India	Local Institution	Chandigarh
India	Local Institution	Chennai
India	Local Institution	Delhi
India	Local Institution	Hyderabad
India	Local Institution	Kerala
India	Local Institution	Kozhikode	Kerala
India	Local Institution	Lucknow
India	Local Institution	Mohali
India	Local Institution	Mumbai
India	Local Institution	Nagpur
India	Local Institution	Pune
India	Local Institution	Pune
India	Local Institution	Pune
India	Local Institution	Pune

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	TKR = Total knee replacement; THR = Total hip replacement. ISTH major bleeding is 1) Fatal or 2) Bleeding in a critical organ, such as brain, spine, eye, retroperitoneum, joint, heart sac, or skeletal muscle (and resulting in compartment syndrome), or 3) 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 bleeding that; 1) Is clinically acute and overt 2) 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	2 weeks + 2 days for TKR, 5 weeks + 2 days for THR
Secondary	Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days	VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism.	2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form