Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban and Aspirin to Aspirin Alone Following Total Hip and Knee Arthroplasty (EPCATIII)
Who is this study for? Patients with Venous Thromboembolism
What treatments are being studied? Acetylsalicylic Acid
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Canada
Queen Elizabeth II HSC
RECRUITING
Halifax
Contact Information
Primary
Susan L Pleasance, BScN
susan.pleasance@nshealth.ca
902-719-5203
Time Frame
Start Date: 2021-02-04
Estimated Completion Date: 2026-04
Participants
Target number of participants: 5400
Treatments
Active_comparator: THA-control arm
Total Hip Arthroplasty: 5 days of rivaroxaban, followed by 30 days of aspirin
Experimental: THA-study arm
Total Hip Arthroplasty: 35 days of aspirin
Active_comparator: TKA-control arm
Total Knee Arthroplasty: 5 days of rivaroxaban, followed by 9 days of aspirin
Experimental: TKA-study arm
Total Knee Arthroplasty: 14 days of aspirin
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, Nova Scotia Health Authority
Leads: Sudeep Shivakumar