Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban and Aspirin to Aspirin Alone Following Total Hip and Knee Arthroplasty (EPCATIII)
Overview
- Phase
- Phase 3
- Intervention
- Rivaroxaban 10 MG and acetylsalicylic acid 81 mg
- Conditions
- Venous Thromboembolism
- Sponsor
- Sudeep Shivakumar
- Enrollment
- 5400
- Locations
- 1
- Primary Endpoint
- Venous thromboembolism
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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 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.
Investigators
Sudeep Shivakumar
Head, Division of Hematology
Nova Scotia Health Authority
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
THA-control arm
Total Hip Arthroplasty: 5 days of rivaroxaban, followed by 30 days of aspirin
Intervention: Rivaroxaban 10 MG and acetylsalicylic acid 81 mg
THA-study arm
Total Hip Arthroplasty: 35 days of aspirin
Intervention: acetylsalicylic acid 81 mg
TKA-control arm
Total Knee Arthroplasty: 5 days of rivaroxaban, followed by 9 days of aspirin
Intervention: Rivaroxaban 10 MG and acetylsalicylic acid 81 mg
TKA-study arm
Total Knee Arthroplasty: 14 days of aspirin
Intervention: acetylsalicylic acid 81 mg
Outcomes
Primary Outcomes
Venous thromboembolism
Time Frame: 90 days
symptomatic proximal deep vein thrombosis or pulmonary embolism
Bleeding
Time Frame: 90 days
major and clinically relevant, non-major bleeds
Secondary Outcomes
- Survival(90 days)
- Cost-effectiveness(90 days)