CompletedPhase 3

VTE Prevention Following Total Hip and Knee Arthroplasty

Canada5,429 participantsStarted 2021-02-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients undergoing elective THA/TKA at the participating institutions will be potentially eligible for this study
. Written informed consent in accordance with federal, local and institutional guidelines

Exclusion criteria

. Previous documented VTE (proximal DVT or any PE)
. Hip or lower limb fracture in the previous three months, not related to present surgery
. Metastatic cancer
. Life expectancy less than 6 months
. History of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis
. History of aspirin allergy, active peptic ulcer disease or gastritis that in the judgment of investigator precludes use of aspirin
. History of significant hepatic disease or any other condition that in the judgment of the investigator precludes the use of rivaroxaban
. Creatinine clearance less than 15 ml per minute

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Venous thromboembolism

Timeframe: 90 days

Bleeding

Timeframe: 90 days

Trial details

NCT IDNCT04075240

SponsorSudeep Shivakumar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-16

View on ClinicalTrials.gov More Venous Thromboembolism trials