Trial Outcomes & Findings for Xarelto for Thromboprophylaxis After Total Hip and Total Knee Arthroplasty (NCT NCT05449327)
NCT ID: NCT05449327
Last Updated: 2026-04-24
Results Overview
The incidence of both asymptomatic and symptomatic deep vein thrombosis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Up to 3 months after THR and TKR
Results posted on
2026-04-24
Participant Flow
Participants were prospectively enrolled at a single tertiary medical center between February 2023 and December 2025. Patients undergoing total hip or total knee arthroplasty were screened for eligibility.
A total of 158 patients were assessed for eligibility. Eight patients were excluded due to not meeting inclusion or exclusion criteria. A total of 150 patients were enrolled and assigned to the rivaroxaban or control groups.
Participant milestones
| Measure |
Rivaroxaban
The participants are provided with Rivaroxaban 10mg
|
Control
The participants are provided without antithrombotics
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The analysis population included all randomized participants. No participants were excluded from the analysis.
Baseline characteristics by cohort
| Measure |
Rivaroxaban
n=75 Participants
The participants are provided with Rivaroxaban 10mg
|
Control
n=75 Participants
The participants are provided without antithrombotics
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=75 Participants • The analysis population included all randomized participants. No participants were excluded from the analysis.
|
71 years
n=75 Participants • The analysis population included all randomized participants. No participants were excluded from the analysis.
|
70.5 years
n=150 Participants • The analysis population included all randomized participants. No participants were excluded from the analysis.
|
|
Sex: Female, Male
Female
|
49 Participants
n=75 Participants • The analysis population included all randomized participants. No participants were excluded from the analysis.
|
43 Participants
n=75 Participants • The analysis population included all randomized participants. No participants were excluded from the analysis.
|
92 Participants
n=150 Participants • The analysis population included all randomized participants. No participants were excluded from the analysis.
|
|
Sex: Female, Male
Male
|
26 Participants
n=75 Participants • The analysis population included all randomized participants. No participants were excluded from the analysis.
|
32 Participants
n=75 Participants • The analysis population included all randomized participants. No participants were excluded from the analysis.
|
58 Participants
n=150 Participants • The analysis population included all randomized participants. No participants were excluded from the analysis.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Taiwan
|
75 Participants
n=75 Participants • The analysis population included all randomized participants. No participants were excluded from the analysis.
|
75 Participants
n=75 Participants • The analysis population included all randomized participants. No participants were excluded from the analysis.
|
150 Participants
n=150 Participants • The analysis population included all randomized participants. No participants were excluded from the analysis.
|
|
body mass index
|
26.8 kg/m²
n=75 Participants
|
26 kg/m²
n=75 Participants
|
26.6 kg/m²
n=150 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months after THR and TKRThe incidence of both asymptomatic and symptomatic deep vein thrombosis
Outcome measures
| Measure |
Rivaroxaban
n=75 Participants
The participants are provided with Rivaroxaban 10mg
|
Control
n=75 Participants
The participants are provided without antithrombotics
|
|---|---|---|
|
Deep Vein Thrombosis
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months after THR and TKRThe incidence of pulmonary embolism
Outcome measures
| Measure |
Rivaroxaban
n=75 Participants
The participants are provided with Rivaroxaban 10mg
|
Control
n=75 Participants
The participants are provided without antithrombotics
|
|---|---|---|
|
Pulmonary Embolism
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 months after THR and TKRMajor bleeding, infection, and non-healing wound
Outcome measures
| Measure |
Rivaroxaban
n=75 Participants
The participants are provided with Rivaroxaban 10mg
|
Control
n=75 Participants
The participants are provided without antithrombotics
|
|---|---|---|
|
Complication
|
5 Participants
|
1 Participants
|
Adverse Events
Rivaroxaban
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rivaroxaban
n=75 participants at risk
The participants are provided with Rivaroxaban 10mg
|
Control
n=75 participants at risk
The participants are provided without antithrombotics
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/75 • From the day of surgery until 3 months postoperatively.
Adverse events were assessed prospectively from the day of surgery until 3 months postoperatively. Deep vein thrombosis was detected by routine duplex ultrasonography on postoperative day 3 and day 14, and symptomatic venous thromboembolism was evaluated clinically during follow-up visits. Major bleeding events were defined as gastrointestinal or intracranial hemorrhage requiring medical intervention. All randomized participants were included in the adverse event analysis.
|
1.3%
1/75 • From the day of surgery until 3 months postoperatively.
Adverse events were assessed prospectively from the day of surgery until 3 months postoperatively. Deep vein thrombosis was detected by routine duplex ultrasonography on postoperative day 3 and day 14, and symptomatic venous thromboembolism was evaluated clinically during follow-up visits. Major bleeding events were defined as gastrointestinal or intracranial hemorrhage requiring medical intervention. All randomized participants were included in the adverse event analysis.
|
|
Vascular disorders
Symptoms of deep vein thrombosis (coldness, pain, cyanosis, swelling, or skin changes)
|
5.3%
4/75 • From the day of surgery until 3 months postoperatively.
Adverse events were assessed prospectively from the day of surgery until 3 months postoperatively. Deep vein thrombosis was detected by routine duplex ultrasonography on postoperative day 3 and day 14, and symptomatic venous thromboembolism was evaluated clinically during follow-up visits. Major bleeding events were defined as gastrointestinal or intracranial hemorrhage requiring medical intervention. All randomized participants were included in the adverse event analysis.
|
9.3%
7/75 • From the day of surgery until 3 months postoperatively.
Adverse events were assessed prospectively from the day of surgery until 3 months postoperatively. Deep vein thrombosis was detected by routine duplex ultrasonography on postoperative day 3 and day 14, and symptomatic venous thromboembolism was evaluated clinically during follow-up visits. Major bleeding events were defined as gastrointestinal or intracranial hemorrhage requiring medical intervention. All randomized participants were included in the adverse event analysis.
|
|
Blood and lymphatic system disorders
Wound bleeding
|
6.7%
5/75 • From the day of surgery until 3 months postoperatively.
Adverse events were assessed prospectively from the day of surgery until 3 months postoperatively. Deep vein thrombosis was detected by routine duplex ultrasonography on postoperative day 3 and day 14, and symptomatic venous thromboembolism was evaluated clinically during follow-up visits. Major bleeding events were defined as gastrointestinal or intracranial hemorrhage requiring medical intervention. All randomized participants were included in the adverse event analysis.
|
1.3%
1/75 • From the day of surgery until 3 months postoperatively.
Adverse events were assessed prospectively from the day of surgery until 3 months postoperatively. Deep vein thrombosis was detected by routine duplex ultrasonography on postoperative day 3 and day 14, and symptomatic venous thromboembolism was evaluated clinically during follow-up visits. Major bleeding events were defined as gastrointestinal or intracranial hemorrhage requiring medical intervention. All randomized participants were included in the adverse event analysis.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
9.3%
7/75 • From the day of surgery until 3 months postoperatively.
Adverse events were assessed prospectively from the day of surgery until 3 months postoperatively. Deep vein thrombosis was detected by routine duplex ultrasonography on postoperative day 3 and day 14, and symptomatic venous thromboembolism was evaluated clinically during follow-up visits. Major bleeding events were defined as gastrointestinal or intracranial hemorrhage requiring medical intervention. All randomized participants were included in the adverse event analysis.
|
4.0%
3/75 • From the day of surgery until 3 months postoperatively.
Adverse events were assessed prospectively from the day of surgery until 3 months postoperatively. Deep vein thrombosis was detected by routine duplex ultrasonography on postoperative day 3 and day 14, and symptomatic venous thromboembolism was evaluated clinically during follow-up visits. Major bleeding events were defined as gastrointestinal or intracranial hemorrhage requiring medical intervention. All randomized participants were included in the adverse event analysis.
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/75 • From the day of surgery until 3 months postoperatively.
Adverse events were assessed prospectively from the day of surgery until 3 months postoperatively. Deep vein thrombosis was detected by routine duplex ultrasonography on postoperative day 3 and day 14, and symptomatic venous thromboembolism was evaluated clinically during follow-up visits. Major bleeding events were defined as gastrointestinal or intracranial hemorrhage requiring medical intervention. All randomized participants were included in the adverse event analysis.
|
0.00%
0/75 • From the day of surgery until 3 months postoperatively.
Adverse events were assessed prospectively from the day of surgery until 3 months postoperatively. Deep vein thrombosis was detected by routine duplex ultrasonography on postoperative day 3 and day 14, and symptomatic venous thromboembolism was evaluated clinically during follow-up visits. Major bleeding events were defined as gastrointestinal or intracranial hemorrhage requiring medical intervention. All randomized participants were included in the adverse event analysis.
|
Additional Information
Cheng-Ming Chou
Department of Orthopedics, Ditmanson Medical Foundation Chia- Yi Christian Hospital, Chia-Yi City, Taiwan
Phone: 88652765041
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place