VTE Prevention Following Total Hip and Knee Arthroplasty
NCT ID: NCT04075240
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
5400 participants
INTERVENTIONAL
2021-02-04
2026-04-30
Brief Summary
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Detailed Description
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This study will assess if aspirin alone is non-inferior to rivaroxaban and aspirin in the prevention of venous thromboembolism.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
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THA-control arm
Total Hip Arthroplasty: 5 days of rivaroxaban, followed by 30 days of aspirin
Rivaroxaban 10 MG and acetylsalicylic acid 81 mg
Starting post op, rivaroxaban (5 days) followed by aspirin (9 days for TKA; 30 days for THA)
THA-study arm
Total Hip Arthroplasty: 35 days of aspirin
acetylsalicylic acid 81 mg
Starting post op, aspirin for 9 days for TKA and 30 days for THA
TKA-control arm
Total Knee Arthroplasty: 5 days of rivaroxaban, followed by 9 days of aspirin
Rivaroxaban 10 MG and acetylsalicylic acid 81 mg
Starting post op, rivaroxaban (5 days) followed by aspirin (9 days for TKA; 30 days for THA)
TKA-study arm
Total Knee Arthroplasty: 14 days of aspirin
acetylsalicylic acid 81 mg
Starting post op, aspirin for 9 days for TKA and 30 days for THA
Interventions
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Rivaroxaban 10 MG and acetylsalicylic acid 81 mg
Starting post op, rivaroxaban (5 days) followed by aspirin (9 days for TKA; 30 days for THA)
acetylsalicylic acid 81 mg
Starting post op, aspirin for 9 days for TKA and 30 days for THA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Written informed consent in accordance with federal, local and institutional guidelines
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Nova Scotia Health Authority
OTHER
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
NETWORK
Sudeep Shivakumar
OTHER
Responsible Party
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Sudeep Shivakumar
Head, Division of Hematology
Principal Investigators
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Sudeep P Shivakumar, MD
Role: PRINCIPAL_INVESTIGATOR
Dalhousie University/Nova Scotia Health Authority
Locations
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Queen Elizabeth II HSC
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EPCATIII.001
Identifier Type: -
Identifier Source: org_study_id
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