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Can a Two-Drug combo beat aspirin alone for preventing clots after joint surgery?

NCT ID NCT04075240

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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