VTE Prevention Following Total Hip and Knee Arthroplasty

Venous Thromboembolism Clinical Trial

— EPCATIII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075240
• Other study ID #: EPCATIII.001
• Status: Recruiting
• Phase: Phase 3
• Start date: February 4, 2021
• Est. completion date: April 2026

Study information

• Verified date: February 2024
• Source: Nova Scotia Health Authority
• Contact: Susan L Pleasance, BScN
• Phone: 902-719-5203
• Email: susan.pleasance[@]nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5400
• Est. completion date: April 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients undergoing elective THA/TKA at the participating institutions will be potentially eligible for this study

2. Written informed consent in accordance with federal, local and institutional guidelines

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 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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

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)
• acetylsalicylic acid 81 mg
Starting post op, aspirin for 9 days for TKA and 30 days for THA

Locations

Country	Name	City	State
Canada	Queen Elizabeth II HSC	Halifax	Nova Scotia

Sponsors (4)

Lead Sponsor	Collaborator
Sudeep Shivakumar	Canadian Institutes of Health Research (CIHR), Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thromboembolism	symptomatic proximal deep vein thrombosis or pulmonary embolism	90 days
Primary	Bleeding	major and clinically relevant, non-major bleeds	90 days
Secondary	Survival	all cause death	90 days
Secondary	Cost-effectiveness	quantitatively describe the costs of symptomatic thromboembolism events and major bleeding episodes	90 days