Trial Outcomes & Findings for Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery (NCT NCT01884337)

Last Updated: 2019-11-29

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

557 participants

Primary outcome timeframe

2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

Results posted on

2019-11-29

Participant Flow

This study was conducted in an Indian orthopedic population.

557 participants were enrolled, of whom 498 were treated. Of the 59 who were not treated, 42 no longer met study criteria, 6 withdrew consent, 11 due to other reasons. Of the 326 who started Total Knee Replacement, 324 continued into follow-up period and of the 172 who started Total Hip Replacement, 170 continued into follow-up period.

Participant milestones

Participant milestones
Measure	Total Knee Replacement (TKR) Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks	Total Hip Replacement (THR) Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks
Treatment STARTED	326	172
Treatment Continuing Into Follow-up Period	324	171
Treatment COMPLETED	322	170
Treatment NOT COMPLETED	4	2
Follow-up Period STARTED	324	171
Follow-up Period COMPLETED	323	170
Follow-up Period NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Knee Replacement (TKR) Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks	Total Hip Replacement (THR) Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks
Treatment Adverse Event	2	2
Treatment Subj. request to discont. treatment	2	0
Follow-up Period Lost to Follow-up	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Knee Replacement (TKR) n=326 Participants Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks	Total Hip Replacement (THR) n=172 Participants Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks	Total n=498 Participants Total of all reporting groups
Age, Continuous	60.7 Years STANDARD_DEVIATION 9.59 • n=5 Participants	41.7 Years STANDARD_DEVIATION 13.30 • n=7 Participants	54.1 Years STANDARD_DEVIATION 11.01 • n=5 Participants
Sex: Female, Male Female	237 Participants n=5 Participants	53 Participants n=7 Participants	290 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	119 Participants n=7 Participants	208 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	322 Participants n=5 Participants	163 Participants n=7 Participants	485 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	326 Participants n=5 Participants	172 Participants n=7 Participants	498 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

Population: All participants who received at least one dose of study drug during the Treatment Period

Outcome measures

Outcome measures
Measure	Total Knee Replacement (TKR) n=326 Participants Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks	Total Hip Replacement (THR) n=172 Participants Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks
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 Major or Clinically Relevant Non-Major Bleeding	0 Participants	1 Participants
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 Major Bleeding	0 Participants	0 Participants
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 Clinically Relevant Non-Major Bleeding	0 Participants	1 Participants
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 Any Bleeding	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

Population: All participants who received at least one dose of study drug

VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism.

Outcome measures

Outcome measures
Measure	Total Knee Replacement (TKR) n=326 Participants Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks	Total Hip Replacement (THR) n=172 Participants Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks
Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days	1 Participants	1 Participants

Adverse Events

TOTAL KNEE REPLACEMENT (TKR)

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

TOTAL HIP REPLACEMENT (THR)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TOTAL KNEE REPLACEMENT (TKR) n=326 participants at risk Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks	TOTAL HIP REPLACEMENT (THR) n=172 participants at risk Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks
Blood and lymphatic system disorders Anaemia	0.31% 1/326 • AEs are assessed from Day 1 through Day 42 +/- 2 days for Total Knee Replacement Participants; AEs are assessed from Day 1 through Day 65 +/-2 days for Total Hip Replacement Participants.	0.00% 0/172 • AEs are assessed from Day 1 through Day 42 +/- 2 days for Total Knee Replacement Participants; AEs are assessed from Day 1 through Day 65 +/-2 days for Total Hip Replacement Participants.
Ear and labyrinth disorders Vertigo	0.31% 1/326 • AEs are assessed from Day 1 through Day 42 +/- 2 days for Total Knee Replacement Participants; AEs are assessed from Day 1 through Day 65 +/-2 days for Total Hip Replacement Participants.	0.00% 0/172 • AEs are assessed from Day 1 through Day 42 +/- 2 days for Total Knee Replacement Participants; AEs are assessed from Day 1 through Day 65 +/-2 days for Total Hip Replacement Participants.
Vascular disorders Deep vein thrombosis	0.31% 1/326 • AEs are assessed from Day 1 through Day 42 +/- 2 days for Total Knee Replacement Participants; AEs are assessed from Day 1 through Day 65 +/-2 days for Total Hip Replacement Participants.	0.00% 0/172 • AEs are assessed from Day 1 through Day 42 +/- 2 days for Total Knee Replacement Participants; AEs are assessed from Day 1 through Day 65 +/-2 days for Total Hip Replacement Participants.

Other adverse events

Other adverse events
Measure	TOTAL KNEE REPLACEMENT (TKR) n=326 participants at risk Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks	TOTAL HIP REPLACEMENT (THR) n=172 participants at risk Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks
Injury, poisoning and procedural complications Incision site pain	7.1% 23/326 • AEs are assessed from Day 1 through Day 42 +/- 2 days for Total Knee Replacement Participants; AEs are assessed from Day 1 through Day 65 +/-2 days for Total Hip Replacement Participants.	3.5% 6/172 • AEs are assessed from Day 1 through Day 42 +/- 2 days for Total Knee Replacement Participants; AEs are assessed from Day 1 through Day 65 +/-2 days for Total Hip Replacement Participants.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER