This trial is active, not recruiting.

Condition venous thromboembolism
Treatment rivaroxaban and asa
Phase phase 3
Sponsor David Anderson
Collaborator Canadian Institutes of Health Research (CIHR)
Start date February 2013
End date December 2016
Trial size 3426 participants
Trial identifier NCT01720108, EPCATII.001


In this study the investigators want to look at whether using aspirin instead of rivaroxaban (after initial treatment with rivaroxaban) works as well at preventing blood clots while also reducing risk of bleeding and is more cost effective in patients who have either a total hip replacement or total knee replacement.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
(Active Comparator)
rivaroxaban 10mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients
rivaroxaban and asa
ASA 81mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients
rivaroxaban and asa

Primary Outcomes

symptomatic venous thromboembolism
time frame: up to 4 years
major or clinically relevant non-major bleeding
time frame: up to 4 years

Secondary Outcomes

time frame: up to 4 years
myocardial infarction
time frame: up to 4 years
time frame: up to 4 years
wound infection
time frame: up to 4 years
time frame: up to 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. All patients undergoing elective total hip or knee arthroplasty at the participating institutions will be potentially eligible for this study Exclusion Criteria: 1. Hip or lower limb fracture in the previous three months 2. Metastatic cancer 3. Life expectancy less than 6 months 4. History of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis 5. History of aspirin allergy, active peptic ulcer disease or gastritis that in judgment of investigator precludes use of aspirin 6. History of significant hepatic disease or any other condition that in the judgement of the investigator precludes the use of rivaroxaban 7. Creatinine clearance less than 30 ml per minute 8. Platelet count less than 100 x 109 /L 9. Need for long-term anticoagulation due to a preexisting co-morbid condition or due to the development of venous thromboembolism following surgery but prior to randomization 10. Did not or will not receive rivaroxaban post-operatively for VTE prophylaxis 11. Bilateral total hip arthroplasty or simultaneous hip and knee arthroplasty 12. Major surgical procedure within the previous three months 13. Requirement for major surgery post arthroplasty within 90 day period 14. Chronic daily aspirin use with dose greater than 100 mg a day 15. Women of child bearing potential who are not abstinent or do not use appropriate contraception throughout the study drug period 16. Geographical inaccessibility for follow-up 17. Unwilling or unable to give consent 18. Previous participation in the study 19. Concomitant use with drugs that are strong inhibitors or inducers of both P-gp and CYP3A4

Additional Information

Official title Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty
Principal investigator David R Anderson, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Nova Scotia Health Authority.