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A randomized controlled trial of aspirin or rivaroxaban for the prevention of venous thromboembolism after primary total hip and total knee arthroplasty

A randomized controlled trial of aspirin or rivaroxaban for the prevention of venous thromboembolism after primary total hip and total knee arthroplasty

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092488
Enrollment
Unknown
Registered
2024-11-18
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Osteoarthritis,Rheumatoid Arthritis,Kashin-Beck Disease,Developmental Dislocation of the Hip,Avascular Necrosis of the Femoral Head,Ankylosing Spondylitis

Interventions

Experimental Group:Total knee arthroplasty (TKA) patients: Aspirin group: Oral aspirin 100 mg, twice daily, for a duration of 14 days. Total hip arthroplasty (THA) patients: Aspirin group: Oral aspiri
Control Group: Total knee arthroplasty (TKA) patients: Rivaroxaban group: Oral rivaroxaban 10 mg, once daily, for a duration of 14 days. Total hip arthroplasty (THA) patients: Rivaroxaban group

Sponsors

Department of Orthopedics, the First Affliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: I. Center Inclusion Criteria: 1. Participating department or surgical team agrees to adhere to the study protocol 2. Use of intermittent pneumatic compression postoperatively until patient mobilization 3. Initiation of affected limb mobilization on postoperative day 1 or earlier 4. Maintain consistent VTE-related clinical practices during the study (e.g., tourniquet use, anesthesia methods, etc.) II. Patient Inclusion Criteria: 1. Adults aged 18 years or older 2. Undergoing elective, primary, unilateral total knee or total hip arthroplasty

Exclusion criteria

Exclusion criteria: Patient Exclusion Criteria: 1. Partial compartment joint replacement 2. Non-osteoarthritis etiology 3. Preoperative use of warfarin, novel oral anticoagulants, or dual antiplatelet therapy 4. History of hip or lower limb fracture within the past 3 months 5. Metastatic cancer 6. Life expectancy less than 6 months 7. History of significant bleeding, deemed unsuitable for anticoagulant prophylaxis by the investigator 8. History of aspirin allergy, active peptic ulcer, or gastritis, deemed unsuitable for aspirin use by the investigator 9. History of severe liver disease or other conditions deemed unsuitable for rivaroxaban use by the investigator 10. Creatinine clearance 100 mg/day 18. Women of childbearing potential not abstaining or not using appropriate contraception during the study drug period, or currently breastfeeding 19. Geographical barriers to follow-up, unable to be followed up 20. Previous participation in this study

Design outcomes

Primary

MeasureTime frame
Incidence of symptomatic VTE;Healthcare resource utilization;

Secondary

MeasureTime frame
Bleeding events;Readmission rate;Reoperation rate;Mortality rate;Patient adherence;

Countries

China

Contacts

Public ContactLi Cao

The First Affliated Hospital of Xinjiang Medical University

xjbone@163.com+86 139 0991 5960

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026