NCT04075240

VTE Prevention Following Total Hip and Knee Arthroplasty

Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban and Aspirin to Aspirin Alone Following Total Hip and Knee Arthroplasty (EPCATIII)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,400 (estimated)
• Sponsor: Sudeep Shivakumar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	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)
DRUG	acetylsalicylic acid 81 mg	Starting post op, aspirin for 9 days for TKA and 30 days for THA

Timeline

• Start date: 2021-02-04
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2019-08-30
• Last updated: 2024-02-07

Locations

1 site across 1 country: Canada