Anticoagulation
Conditions
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
Interventions
DRUGApixaban
Sponsors
Pfizer
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days | 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR | VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism. |
Countries
India
Participant flow
Recruitment details
This study was conducted in an Indian orthopedic population.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Total Knee Replacement (TKR) Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks | 326 |
| Total Hip Replacement (THR) Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks | 172 |
| Total | 498 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up Period | Lost to Follow-up | 1 | 1 |
| Treatment | Adverse Event | 2 | 2 |
| Treatment | Subj. request to discont. treatment | 2 | 0 |
Baseline characteristics
| Characteristic | Total Hip Replacement (THR) | Total | Total Knee Replacement (TKR) |
|---|---|---|---|
| Age, Continuous | 41.7 Years STANDARD_DEVIATION 13.3 | 54.1 Years STANDARD_DEVIATION 11.01 | 60.7 Years STANDARD_DEVIATION 9.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 12 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 163 Participants | 485 Participants | 322 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 172 Participants | 498 Participants | 326 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 53 Participants | 290 Participants | 237 Participants |
| Sex: Female, Male Male | 119 Participants | 208 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 326 | 0 / 172 |
| other Total, other adverse events | 23 / 326 | 6 / 172 |
| serious Total, serious adverse events | 2 / 326 | 0 / 172 |
Outcome results
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
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Knee Replacement (TKR) | 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 |
| Total Knee Replacement (TKR) | 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 |
| Total Knee Replacement (TKR) | 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 |
| Total Knee Replacement (TKR) | 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 |
| Total Hip Replacement (THR) | 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 | 1 Participants |
| Total Hip Replacement (THR) | 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 |
| Total Hip Replacement (THR) | 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 | 1 Participants |
| Total Hip Replacement (THR) | 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 | 1 Participants |
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.
Time frame: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR
Population: All participants who received at least one dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Knee Replacement (TKR) | Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days | 1 Participants |
| Total Hip Replacement (THR) | Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days | 1 Participants |