Status:
RECRUITING
VTE Prevention Following Total Hip and Knee Arthroplasty
Lead Sponsor:
Sudeep Shivakumar
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Authority
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
Aspirin and rivaroxaban prevent venous thromboembolism (VTE) via different mechanisms. Aspirin is significantly cheaper than rivaroxaban. Aspirin in combination with rivaroxaban was shown to be safe a...
Eligibility Criteria
Inclusion
- Patients undergoing elective THA/TKA at the participating institutions will be potentially eligible for this study
- Written informed consent in accordance with federal, local and institutional guidelines
Exclusion
- Previous documented VTE (proximal DVT or any PE)
- Hip or lower limb fracture in the previous three months, not related to present surgery
- Metastatic cancer
- Life expectancy less than 6 months
- History of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis
- History of aspirin allergy, active peptic ulcer disease or gastritis that in the judgment of investigator precludes use of aspirin
- History of significant hepatic disease or any other condition that in the judgment of the investigator precludes the use of rivaroxaban
- Creatinine clearance less than 15 ml per minute
- Pre-operative platelet count less than 100 x 109 /L
- 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
- Received anticoagulation post operatively
- Bilateral THA/TKA or simultaneous hip and knee arthroplasty
- Major surgical procedure within the previous 3 months
- Requirement for major surgery post arthroplasty within a 90 day period
- Chronic daily aspirin use with dose greater than 100 mg a day
- Women of childbearing potential who are not abstinent or do not use effective contraception or are breast-feeding throughout the study drug period
- Unwilling or unable to give consent
- Previous participation in the EPCAT III study
- Under 18 years of age
- 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)
- Known allergy to food dye
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
5400 Patients enrolled
Trial Details
Trial ID
NCT04075240
Start Date
February 4 2021
End Date
April 1 2026
Last Update
February 7 2024
Active Locations (1)
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1
Queen Elizabeth II HSC
Halifax, Nova Scotia, Canada, B3H 3A7