Venous Thromboembolism
Conditions
Keywords
Anticoagulants, Enoxaparin sodium, venous thromboembolism., thromboembolism, Thrombosis, deep vein thrombosis, DU-176b, Edoxaban, factor Xa, hip fracture surgery, embolism
Brief summary
The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.
Interventions
DRUGDU-176b (edoxaban)
DRUGEnoxaparin sodium 20mg
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)
Exclusion criteria
* Subjects with risks of hemorrhage * Subjects with thrombolic risks * Subjects who weigh less than 40 kg * Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Major or Clinically Relevant Non-major Bleeding | 2 weeks | Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Subjects With Venous Thromboembolism Events. | 2 weeks |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DU-176b DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
DU-176b (edoxaban) | 59 |
| Enoxaparin Sodium Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
Enoxaparin sodium 20mg | 29 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Protocol Violation | 3 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | DU-176b | Total | Enoxaparin Sodium |
|---|---|---|---|
| Age, Continuous | 76.5 years STANDARD_DEVIATION 11 | 76.3 years STANDARD_DEVIATION 11.2 | 75.6 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 59 Participants | 88 Participants | 29 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 |
| Region of Enrollment Japan | 59 participants | 88 participants | 29 participants |
| Sex: Female, Male Female | 48 Participants | 70 Participants | 22 Participants |
| Sex: Female, Male Male | 11 Participants | 18 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 43 / 59 | 24 / 29 |
| serious Total, serious adverse events | 3 / 59 | 3 / 29 |
Outcome results
Primary
The Incidence of Major or Clinically Relevant Non-major Bleeding
Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.
Time frame: 2 weeks
Population: Safety Analysis Set defined as all subjects who were secondarily enrolled in study, but excluded those with significant GCP violations, did not receive any study drug, or had no safety data after start of study treatment. However, subjects who had significant GCP violations, but received at least one dose of study drug, safety data were assessed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DU-176b | The Incidence of Major or Clinically Relevant Non-major Bleeding | 3.4 percentage of subjects with bleeds |
| Enoxaparin Sodium | The Incidence of Major or Clinically Relevant Non-major Bleeding | 6.9 percentage of subjects with bleeds |
95% CI: [-18.8, 6]Wilcoxon (Mann-Whitney)
Secondary
Proportion of Subjects With Venous Thromboembolism Events.
Time frame: 2 weeks