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Could a daily pill replace painful shots for leg injury patients?

NCT ID NCT06195540

Disease control Sponsor: University Hospital, Angers Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study compares a daily pill (rivaroxaban) to daily injections (low-molecular-weight heparin) for preventing blood clots in people with leg injuries that require a cast or brace. About 1,424 high-risk participants will be randomly assigned to one of the two treatments and followed for 90 days. The goal is to see if the pill is at least as effective and easier for patients to use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rivaroxaban (a blood-thinning pill)
What this could lead to
If it works, patients with leg trauma could take a simple daily pill instead of daily injections to prevent dangerous blood clots, improving convenience and comfort.
What could go wrong
This is a large phase 3 trial, but it's comparing two existing drugs, so it's not a breakthrough. There is a risk of bleeding with any blood thinner, and the study may not show a clear advantage.

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

About 1,424 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Patient aged 18 or over ; * Consultation in an emergency department of a participating centre; * Trauma to the lower limb requiring rigid or semi-rigid orthopaedic immobilisation; * Expected duration of orthopaedic immobilisation of at least 2 weeks; * TRiP(cast) score ≥ 7 ; * Patient affiliated to or benefiting from a social security scheme; * Patient with prior informed consent. Exclusion Criteria: * Patient that have to be hospitalized after emergency department for other reason than lower limb trauma * Active bleeding or high risk of bleeding, * Known contraindication to rivaroxaban or LMWH; * Taking any anticoagulant or antiplatelet agent before the trauma (only antithrombotic authorised: aspirin \< 325mg/d); * Pregnant or breastfeeding woman; * Any factor making 3-month follow-up impossible; 6. Patient subject to a legal protection measure, Imprisonment 7. Participation in any interventional study which modifies patient care or could influence study evaluation criteria

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Conditions

The condition(s) this trial relates to.

Emergencies injury pulmonary embolism Venous Thrombosis venous thromboembolism prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Deep vein thrombosis Immobilisation Lower limb trauma Pulmonary embolism Thromboprophylaxis Venous thromboembolism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Agen-Nerac Hospital, Emergency Department

    ACTIVE_NOT_RECRUITING

    Agen, 47923, France

  • Angers University Hospital, Emergency department

    RECRUITING

    Angers, 49000, France

  • Argenteuil hospital, Emergency department

    RECRUITING

    Argenteuil, 95100, France

  • Arpajon Hospital, Emergency Department

    WITHDRAWN

    Arpajon, 91294, France

  • Bichat Hospital, Adult Emergency department

    RECRUITING

    Paris, 75018, France

  • Caen University hospital, Emergency department

    WITHDRAWN

    Caen, 14000, France

  • Cholet Hospital, Emergency department

    RECRUITING

    Cholet, 49300, France

  • Clermont-Ferrand University Hospital, Emergency department

    RECRUITING

    Clermont-Ferrand, 63000, France

  • Cochin Hospital, Emergency department

    RECRUITING

    Paris, 75014, France

  • Edouard Herriot University Hospital, Emergency Department

    RECRUITING

    Lyon, 69000, France

  • Eure-Seine Hospital, Emergency Departement

    ACTIVE_NOT_RECRUITING

    Évreux, 27015, France

  • Grenoble University Hospital, Emergency Department

    RECRUITING

    Grenoble, 38000, France

  • HEGP, Emergency Department

    RECRUITING

    Paris, 75015, France

  • La Pitié-Salpétrière Hospital, Emergency Department

    NOT_YET_RECRUITING

    Paris, 75013, France

  • La Roche sur Yon Hospital

    NOT_YET_RECRUITING

    La Roche-sur-Yon, 85000, France

  • La Rochelle Hospital, Adult emergency departement

    RECRUITING

    La Rochelle, 17000, France

  • Lariboisière hospital, emergency department

    NOT_YET_RECRUITING

    Paris, 75010, France

  • Le Mans Hospital, Emergency department

    RECRUITING

    Le Mans, 72000, France

  • Limoges University hospital, Emergency department

    RECRUITING

    Limoges, 87000, France

  • Marseille University Hospital, Emergency department

    RECRUITING

    Marseille, 13005, France

  • Melun Hospital, Emergency Department

    RECRUITING

    Melun, 77000, France

  • Montpellier University Hospital, emergency department

    RECRUITING

    Montpellier, 34000, France

  • Nancy University Hospital, Emergency department

    NOT_YET_RECRUITING

    Nancy, 54000, France

  • Nantes University Hospital, Emergency department

    RECRUITING

    Nantes, 44000, France

  • Nice University Hospital, Emergency department

    WITHDRAWN

    Nice, 06000, France

  • Niort Hospital, Emergency Department

    RECRUITING

    Niort, 79000, France

  • Poitiers University Hospital, Emergency department

    RECRUITING

    Poitiers, 86000, France

  • Rennes University Hospital, Emergency department

    RECRUITING

    Rennes, 35000, France

  • Rouen University Hospital, Emergency Department

    NOT_YET_RECRUITING

    Rouen, 76000, France

  • Saint-Antoine Hospital, Emergency department

    RECRUITING

    Paris, 75012, France

  • Simone Veil Hospital, Emergency Department

    RECRUITING

    Eaubonne, 95600, France

  • South Lyon University Hospital, Emergency department

    RECRUITING

    Pierre-Bénite, 69495, France

  • St-Joseph Hospital, Emergency Department

    RECRUITING

    Paris, 75014, France

  • Strasbourg University Hospital, Emergency Department

    RECRUITING

    Strasbourg, 67000, France

  • Toulouse University Hospital, Emergency Department

    RECRUITING

    Toulouse, 31000, France

  • Tours University Hospital, Emergency department

    WITHDRAWN

    Chambray-lès-Tours, 37170, France

  • Vannes Hospital, Emergency Department

    RECRUITING

    Vannes, 56000, France

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