A Phase 4 interventional study of Apixaban in Anticoagulation, sponsored by Bristol-Myers Squibb. Completed at 20 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-29.
Sponsored by Bristol-Myers Squibb · Phase 4, Interventional, and Treatment
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
Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Apixaban 2.5 mg tablets by mouth twice daily, 12 days for TKR subjects or 35 days for THR subjects
Drug: Apixaban
Also known as: Eliquis, BMS-562247
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
Time frame: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR
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.
Time frame: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR
This study was conducted in an Indian orthopedic population.
| Milestone | Total Knee Replacement (TKR) | Total Hip Replacement (THR) |
|---|---|---|
| Started | 326 | 172 |
| Continuing into follow-up period | 324 | 171 |
| Completed | 322 | 170 |
| Not completed | 4 | 2 |
| Withdrew: Adverse event | 2 | 2 |
| Withdrew: Subj. request to discont. treatment | 2 | 0 |
| Milestone | Total Knee Replacement (TKR) | Total Hip Replacement (THR) |
|---|---|---|
| Started | 324 | 171 |
| Completed | 323 | 170 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
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
| Participants | Total Knee Replacement (TKR) | Total Hip Replacement (THR) |
|---|---|---|
| Major Bleeding | 0 | 0 |
| Clinically Relevant Non-Major Bleeding | 0 | 1 |
| Major or Clinically Relevant Non-Major Bleeding | 0 | 1 |
| Any Bleeding | 0 | 1 |
VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism.
| Participants | Total Knee Replacement (TKR) | Total Hip Replacement (THR) |
|---|---|---|
| Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days | 1 | 1 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TOTAL KNEE REPLACEMENT (TKR) | 0/326 (0%) | 2/326 (0.6%) | 23/326 (7.1%) |
| TOTAL HIP REPLACEMENT (THR) | 0/172 (0%) | 0/172 (0%) | 6/172 (3.5%) |
| Event | TOTAL KNEE REPLACEMENT (TKR) | TOTAL HIP REPLACEMENT (THR) |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 1/326 | 0/172 |
| VertigoEar and labyrinth disorders | 1/326 | 0/172 |
| Deep vein thrombosisVascular disorders | 1/326 | 0/172 |
| Event | TOTAL KNEE REPLACEMENT (TKR) | TOTAL HIP REPLACEMENT (THR) |
|---|---|---|
| Incision site painInjury, poisoning and procedural complications | 23/326 | 6/172 |
| Age, Continuous(Years) | Total Knee Replacement (TKR) | Total Hip Replacement (THR) | Total |
|---|---|---|---|
| Mean | 60.7 ± 9.59 | 41.7 ± 13.30 | 54.1 ± 11.01 |
| Sex: Female, Male(Participants) | Total Knee Replacement (TKR) | Total Hip Replacement (THR) | Total |
|---|---|---|---|
| Female | 237 | 53 | 290 |
| Male | 89 | 119 | 208 |
| Ethnicity (NIH/OMB)(Participants) | Total Knee Replacement (TKR) | Total Hip Replacement (THR) | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 9 | 12 |
| Not Hispanic or Latino | 322 | 163 | 485 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Total Knee Replacement (TKR) | Total Hip Replacement (THR) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 326 | 172 | 498 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bristol-Myers Squibb