VTE Prevention Following Total Hip and Knee Arthroplasty

Last updated: February 6, 2024
Sponsor: Sudeep Shivakumar
Overall Status: Active - Recruiting

Phase

3

Condition

Venous Thromboembolism

Thromboembolism

Blood Clots

Treatment

acetylsalicylic acid 81 mg

Rivaroxaban 10 MG and acetylsalicylic acid 81 mg

Clinical Study ID

NCT04075240
EPCATIII.001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients undergoing elective THA/TKA at the participating institutions will bepotentially eligible for this study
  2. Written informed consent in accordance with federal, local and institutionalguidelines

Exclusion

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 presentsurgery
  3. Metastatic cancer
  4. Life expectancy less than 6 months
  5. History of major bleeding that in the judgment of the investigator precludes use ofanticoagulant prophylaxis
  6. History of aspirin allergy, active peptic ulcer disease or gastritis that in thejudgment of investigator precludes use of aspirin
  7. History of significant hepatic disease or any other condition that in the judgment ofthe 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 tothe 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 effectivecontraception 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., systemictreatment with ketoconazole, itraconazole, or ritonavir) or strong inducers of P-gpAND CYP3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, St. John'sWort)
  21. Known allergy to food dye

Study Design

Total Participants: 5400
Treatment Group(s): 2
Primary Treatment: acetylsalicylic acid 81 mg
Phase: 3
Study Start date:
February 04, 2021
Estimated Completion Date:
April 30, 2026

Study 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 and efficacious in a non-inferiority trial (EPCATII) when compared to rivaroxaban alone.

This study will assess if aspirin alone is non-inferior to rivaroxaban and aspirin in the prevention of venous thromboembolism.

Connect with a study center

  • Queen Elizabeth II HSC

    Halifax, Nova Scotia B3H 3A7
    Canada

    Active - Recruiting

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