Venous ThromboembolismNCT05449327
Xarelto for Thromboprophylaxis After Total Hip and Total Knee Arthroplasty
A study testing Rivaroxaban 10 MG in people with Venous Thromboembolism and Arthroplasty, run by Chiayi Christian Hospital at 1 site in Taiwan.
Trial summary
Venous thromboembolism is a serious complication after total hip replacement (THR) and total knee replacement (TKR). Previous studies have reported the incidence of both asymptomatic and symptomatic deep vein thrombosis (DVT) after TKR were higher in Taiwan than other countries in Asia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Venous Thromboembolism, Arthroplasty
- What is being tested?
- Rivaroxaban 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2023to 21 Sep 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergo total knee replacement or total hip replacement
Who cannot join
- Recent antithrombotics use
- A history of a coagulopathy
- Recent thromboembolic disease
- Preoperative deep vein thrombosis screening presents positive
- Age below 20
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Ditmanson Medical Foundation Chiayi Christian Hospital
Chiayi City, Taiwan, 60002
About this study
Venous thromboembolism is a serious complication after total hip replacement (THR) and total knee replacement (TKR). Previous studies have reported the incidence of both asymptomatic and symptomatic deep vein thrombosis (DVT) after TKR were higher in Taiwan than other countries in Asia. Therefore, the usage of prophylactic antithrombotics should be considered. The efficacy and safety of Xarelto (Rivaroxaban) for preventing venous thromboembolism has been proved. However, there is a lack of study using prospective design to evaluate the efficacy and safety of Xarelto after THR and TKR for Taiwanese. In this study, the investigators use a randomized controlled trial design comparing the incidence of DVT, pulmonary embolism, and complications between intervention and control groups.
Read the detailed description
This parallel study is conducted in a single hospital. The participants are divided into two groups. One group is provided with Xarelto, and the other one group is provided without any prophylactic antithrombotic. To check the presence of a deep vein thrombosis of the lower limb, bilateral sonographic examinations are arranged for all participants preoperatively and at 3 and 14 days postoperatively. One radiologists who was blinded to the nature of the study interpreted the results of the sonographic examination. The present of pulmonary embolism, DVT-related symptoms, and complications are recorded during the 3-months follow-up in orthopedics outpatients. The symptom which associated with DVT is defined as the signs of leg such as unusual pain, edema, swelling, warm skin, and red or discolored skin. Complications related to Xarelto include major bleeding, infection, and non-healing wound. The expected number of participants in each group is 89, which is calculated by G * Power version 3.1. The intention to treat analysis is used in this study. The investigators compare the incidences of DVT, pulmonary embolism, and complications between the two groups.
- Conditions
- Venous Thromboembolism, Arthroplasty
- Being tested
- Rivaroxaban 10 MG
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 10 MGDrug
Also called Xarelto
Patients are randomly divided into two groups. One group receives no prophylaxis with an anticoagulant, the other one receives Rivaroxaban. The dosage of Rivaroxaban is 10 mg given orally once daily starting on the day of the surgery and continuing the following 13 days.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | The participants are provided with Rivaroxaban 10mg Receives: Drug: Rivaroxaban 10 MG |
| Control | No intervention | The participants are provided without antithrombotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep Vein Thrombosis
The incidence of both asymptomatic and symptomatic deep vein thrombosis
Measured: Up to 3 months after THR and TKR
Pulmonary Embolism
The incidence of pulmonary embolism
Measured: Up to 3 months after THR and TKR
Secondary outcomes (1)
Complication
Major bleeding, infection, and non-healing wound
Measured: Up to 3 months after THR and TKR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Feb 2023
- Primary completion21 Sep 2025
- Study completion21 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449327
- Sponsor's protocol ID
- IRB2021079
- Status last verified
- Apr 2026
- First submitted
- 29 Jun 2022
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No