Can a Two-Drug combo beat aspirin alone for preventing clots after joint surgery?
NCT ID NCT04075240
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This large, completed phase 3 trial enrolled over 5,400 people undergoing total hip or knee replacement to compare two approaches for preventing venous thromboembolism (blood clots). Participants received either aspirin alone or a short course of rivaroxaban followed by aspirin. The study measured how many developed symptomatic clots or experienced bleeding. The goal was to find a safer, more effective prevention strategy for this common surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rivaroxaban (Xarelto) and aspirin
- What this could lead to
- If successful, this could show that adding a short course of rivaroxaban to aspirin is a safe and effective way to prevent dangerous blood clots after joint replacement surgery.
- What could go wrong
- This trial is completed, so results are known. However, the benefit may be modest, and adding rivaroxaban increases bleeding risk. The findings may not apply to people with prior clots or other risk factors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
5,429 people
The number who actually took part.
- Started
-
Feb 2021
- Finished
-
Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Queen Elizabeth II HSC
Halifax, Nova Scotia, B3H 3A7, Canada
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Other studies related to the condition(s) this trial covers.
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