VTE Prevention Following Total Hip and Knee Arthroplasty

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Consented patients undergoing elective total hip and total knee arthroplasty will be randomized to receive either aspirin alone or aspirin and rivaroxaban for prevention of venous thromboembolism.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sudeep Shivakumar
• Collaborators: Canadian Institutes of Health Research (CIHR); Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network; CanVECTOR; Nova Scotia Health Authority
• Treatments: Aspirin; Rivaroxaban

Criteria

Inclusion Criteria:

1. Patients undergoing elective THA/TKA at the participating institutions will be potentially eligible for this study

2. Written informed consent in accordance with federal, local and institutional guidelines

Exclusion Criteria:

1. Previous documented VTE (proximal DVT or any PE)

2. Hip or lower limb fracture in the previous three months, not related to present surgery

3. Metastatic cancer

4. Life expectancy less than 6 months

5. History of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis

6. History of aspirin allergy, active peptic ulcer disease or gastritis that in the judgment of investigator precludes use of aspirin

7. History of significant hepatic disease or any other condition that in the judgment of the investigator precludes the use of rivaroxaban

8. Creatinine clearance less than 15 ml per minute

9. Pre-operative platelet count less than 100 x 109 /L

10. Need for long-term anticoagulation due to a pre-existing co-morbid condition or due to the development of VTE following surgery but prior to randomization

11. Received anticoagulation post operatively

12. Bilateral THA/TKA or simultaneous hip and knee arthroplasty

13. Major surgical procedure within the previous 3 months

14. Requirement for major surgery post arthroplasty within a 90 day period

15. Chronic daily aspirin use with dose greater than 100 mg a day

16. Women of childbearing potential who are not abstinent or do not use effective contraception or are breast-feeding throughout the study drug period

17. Unwilling or unable to give consent

18. Previous participation in the EPCAT III study

19. Under 18 years of age

20. Concomitant use of drugs that are strong inhibitors of P-gp AND CYP3A4 (e.g., systemic treatment with ketoconazole, itraconazole, or ritonavir) or strong inducers of P-gp AND CYP3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's Wort)

21. Known allergy to food dye