Xarelto for Thromboprophylaxis After Total Hip and Total Knee Arthroplasty

NCT05449327 | Completed Results

• 1 other identifier: IRB2021079
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Venous Thromboembolism; Arthroplasty

Outcome Measures

Primary Outcomes (2)

• Deep Vein Thrombosis

  The incidence of both asymptomatic and symptomatic deep vein thrombosis

  Up to 3 months after THR and TKR

• Pulmonary Embolism

  The incidence of pulmonary embolism

  Up to 3 months after THR and TKR

Secondary Outcomes (1)

• Complication

  Up to 3 months after THR and TKR

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

The participants are provided with Rivaroxaban 10mg

Drug: Rivaroxaban 10 MG

Control

NO INTERVENTION

The participants are provided without antithrombotics

Interventions

Rivaroxaban 10 MG DRUG

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.

Also known as: Xarelto

Rivaroxaban

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergo total knee replacement or total hip replacement

You may not qualify if:

• Recent antithrombotics use
• A history of a coagulopathy
• Recent thromboembolic disease
• Preoperative deep vein thrombosis screening presents positive
• Age below 20

Sponsors & Collaborators

• Chiayi Christian Hospital: lead

Study Sites (1)

Ditmanson Medical Foundation Chiayi Christian Hospital

Chiayi City, Taiwan, 60002, Taiwan

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Cheng-Ming Chou
• Organization: Department of Orthopedics, Ditmanson Medical Foundation Chia- Yi Christian Hospital, Chia-Yi City, Taiwan

james58.chou456@msa.hinet.net

88652765041

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 8, 2022
• Study Start: February 1, 2023
• Primary Completion: September 21, 2025
• Study Completion: September 21, 2025
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)