RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing (RIVACAST)

December 1, 2025 updated by: University Hospital, Angers

RIVACAST : RIVAroxaban Versus Low-molecular Weight Heparinin Patients With Lower Limb Trauma Requiring Brace or CASTing

Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score <7 have a very low risk of VTE and could be safely manage without prophylactic treatment. Conversely, patients with a score ≥ 7 have a high-risk of VTE and require a prophylactic anticoagulant treatment. Low molecular weight heparins (LMWH) have been shown to be effective in this indication. However, in the CASTING study, the 3-month symptomatic VTE rate was 2.6% in this subgroup despite LMWH prophylactic treatment. This result suggests that LMWH are not sufficiently effective in this particular subgroup of high-risk patients. Direct oral anticoagulants, and in particular rivaroxaban, may be an effective and safe alternative to LMWH. In the PRONOMOS study, comparing LMWH with rivaroxaban in patients who had undergone non-major lower limb surgery, the relative risk of symptomatic VTE was 0.25 (95% CI = 0.09 - 0.75) in favor of rivaroxaban 10mg. No significant increase in bleeding was found. In addition, as LMWH treatment requires subcutaneous daily injections, the use of rivaroxaban may positively impact patients' quality of life as well as being effective in medico-economic terms.

The aims of this study are to demonstrate that rivaroxaban is at least as effective, easier to use and more efficient than LMWH in patients with trauma to the lower limb requiring immobilisation and deemed to be at risk of venous thromboembolism (TRiP(cast) score ≥ 7). High-risk patients are randomized to receive either rivaroxaban or LMWH. They are followed up at 45 days and 90 days to assess the occurrence of thrombotic events or bleeding, as well as their satisfaction with the treatment received.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1424

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Agen, France, 47923
        • Not yet recruiting
        • Agen-Nerac Hospital, Emergency Department
        • Contact:
      • Angers, France, 49000
        • Recruiting
        • Angers University Hospital, Emergency Department
        • Contact:
      • Argenteuil, France, 95100
      • Arpajon, France, 91294
        • Not yet recruiting
        • Arpajon Hospital, Emergency Department
        • Contact:
      • Caen, France, 14000
        • Withdrawn
        • Caen University hospital, Emergency department
      • Chambray-lès-Tours, France, 37170
        • Withdrawn
        • Tours University Hospital, Emergency department
      • Cholet, France, 49300
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • Clermont-Ferrand University Hospital, Emergency Department
        • Contact:
      • Eaubonne, France, 95600
        • Recruiting
        • Simone Veil Hospital, Emergency Department
        • Contact:
      • Grenoble, France, 38000
        • Recruiting
        • Grenoble University Hospital, Emergency Department
        • Contact:
      • La Rochelle, France, 17000
        • Recruiting
        • La Rochelle Hospital, Adult emergency departement
        • Contact:
      • Le Mans, France, 72000
        • Recruiting
        • Le Mans Hospital, Emergency department
        • Contact:
      • Limoges, France, 87000
        • Recruiting
        • Limoges University hospital, Emergency department
        • Contact:
      • Lyon, France, 69000
        • Recruiting
        • Edouard Herriot University Hospital, Emergency Department
        • Contact:
      • Marseille, France, 13005
        • Recruiting
        • Marseille University Hospital, Emergency department
        • Contact:
      • Melun, France, 77000
        • Not yet recruiting
        • Melun Hospital, Emergency Department
        • Contact:
      • Montpellier, France, 34000
        • Recruiting
        • Montpellier University Hospital, emergency department
        • Contact:
      • Nantes, France, 44000
        • Recruiting
        • Nantes University Hospital, Emergency department
        • Contact:
      • Nice, France, 06000
        • Withdrawn
        • Nice University Hospital, Emergency department
      • Niort, France, 79000
        • Recruiting
        • Niort Hospital, Emergency Department
        • Contact:
      • Paris, France, 75010
        • Not yet recruiting
        • Lariboisière hospital, emergency department
        • Contact:
      • Paris, France, 75013
        • Not yet recruiting
        • La Pitié-Salpétrière Hospital, Emergency Department
        • Contact:
      • Paris, France, 75012
        • Recruiting
        • Saint-Antoine Hospital, Emergency department
        • Contact:
      • Paris, France, 75014
        • Recruiting
        • Cochin Hospital, Emergency department
        • Contact:
      • Paris, France, 75014
        • Recruiting
        • St-Joseph Hospital, Emergency Department
        • Contact:
      • Paris, France, 75015
        • Recruiting
        • HEGP, Emergency Department
        • Contact:
      • Paris, France, 75018
        • Recruiting
        • Bichat Hospital, Adult Emergency department
        • Contact:
      • Pierre-Bénite, France, 69495
        • Recruiting
        • South Lyon University Hospital, Emergency department
        • Contact:
      • Poitiers, France, 86000
        • Recruiting
        • Poitiers University Hospital, Emergency Department
        • Contact:
      • Rennes, France, 35000
        • Recruiting
        • Rennes University Hospital, Emergency department
        • Contact:
      • Rouen, France, 76000
        • Not yet recruiting
        • Rouen University Hospital, Emergency Department
        • Contact:
      • Strasbourg, France, 67000
      • Toulouse, France, 31000
        • Recruiting
        • Toulouse University Hospital, Emergency Department
        • Contact:
      • Vannes, France, 56000
        • Not yet recruiting
        • Vannes Hospital, Emergency Department
        • Contact:
      • Évreux, France, 27015
        • Recruiting
        • Eure-Seine Hospital, Emergency Departement
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rivaroxaban arm
Drug: Rivaroxaban 10 MG

Administration of rivaroxaban 10 mg once daily to prevent venous thromboembolic events in patients with trauma to a lower limb.

Consecutive patients with lower limb trauma and a TRiP(cast) score ≥ 7 are assessed for possible participation in the study. At the inclusion visit, if the patient meets the study's selection criteria, the investigator provides oral and written information (information letter written in a language the patient can understand) and answers any questions the patient may have. Depending on randomisation, the patient will receive either LMWH or rivaroxaban. The dose is rivaroxaban 10 mg orally once a day (no dosage adjustment).

Treatment is started in the emergency department and continued at home for the duration of the immobilisation (i.e. until mobilisation with weight-bearing). The duration of treatment will be determined by the physician.
Active Comparator: Low-molecular-weight heparin arm

Treatment with LMWH is the standard-of-care in this population of lower limb trauma patients at risk of thrombosis.

The control group is therefore the group of patients who receive prophylactic anticoagulant treatment with LMWH for the duration of immobilization (i.e. until full mobilization with weight-bearing).
Drug: Low Heparin Molecular Weight

Administration of standard prophylactic anticoagulant treatment with LMWH for the duration of immobilisation (i.e. until full mobilisation with weight-bearing). Consecutive patients with lower limb trauma and a TRiP(cast) score ≥ 7 are assessed for possible participation in the study. At the inclusion visit, if the patient meets the study's selection criteria, the investigator provides oral and written information (information letter written in a language the patient can understand) and answers any questions the patient may have. Depending on randomisation, the patient will receive either LMWH or rivaroxaban. The dose of LMWH is free, given according to local practices and national recommendations.

Treatment is started in the emergency department and continued at home for the duration of the immobilisation (i.e. until mobilisation with weight-bearing). The duration of treatment will be determined by the physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of symptomatic venous thromboembolic events (45 days non-inferiority)
Time Frame: 45 days

The primary endpoint is the rate of symptomatic venous thromboembolic events (including deep vein thrombosis and/or pulmonary embolism and/or PE-related death) within 45 days (+/- 5 days) of inclusion.

Symptomatic VTE is defined as follows:

  • Deep venous thrombosis (DVT) of the lower limbs: DVT confirmed by a non-compressible venous segment on compression ultrasound or by a filling defect on CT venography. Symptomatic proximal and distal DVTs will be taken into account.
  • Symptomatic pulmonary embolism documented by thoracic angioscan, high probability planar lung scan, SPECT scan, pulmonary angiography or by the combination of documented proximal deep vein thrombosis and thoracic symptomatology suggestive of pulmonary embolism.
  • PE-related deaths according to the ISTH (International Society of Thrombosis and Haemostasis) definition All events will need to be confirmed by the randomisation group's blinded clinical events adjudication committee.
45 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient self reported treatment satisfaction
Time Frame: 45 days
The outcome is patient self-reported treatment satisfaction using the Anti-Clot Treatment Scales (ACTS) assessed at 45 days (+/- 5 days).
45 days
Rate of symptomatic venous thromboembolic events (90 days superiority)
Time Frame: 90 days

This secondary outcome is the cumulative rate of symptomatic venous thromboembolism (i.e., deep venous thrombosis and/or pulmonary embolism) within the 90 days (± 7 days) after the inclusion.

The definition of symptomatic VTE is the same as the primary outcome.
90 days
Cumulative rates of major bleeding and of non-major clinically relevant bleeding (90 days)
Time Frame: 90 days

The cumulative rates of major bleeding and of non-major clinically relevant bleeding at 90 days (± 7 days).

Major bleeding is defined according to the International Society of Thrombosis and Haemostasis (ISTH) criteria and includes:

  • Any bleeding resulting in death
  • Symptomatic bleeding in a critical organ including intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial bleeding and muscle bleeding resulting in compartment syndrome,
  • Symptomatic bleeding resulting in a decrease in the haemoglobin concentration of at least 2g/dL or resulting in the transfusion of at least two packs of blood red cells.

Clinically Relevant Non-Major Bleeding is defined as:

- Any bleeding requiring hospitalisation or a medical intervention including temporary withholding of anticoagulant treatment to stop the bleeding.
90 days
Incremental cost-utility ratio (rivaroxaban efficiency 90 days)
Time Frame: 90 days
The incremental cost-utility ratio (costs per quality-adjusted life year [QALY] gained) assessed at 90 days after inclusion. Health-related quality of life will be collected using EQ-5D-5L self-administered questionnaires at each scheduled follow-up at at 90 days (± 7). Resources consumed will be taken from french national Health Data System.
90 days
Incremental cost-utility ratio (rivaroxaban efficiency 45 days)
Time Frame: 45 days
The incremental cost-utility ratio (costs per quality-adjusted life year (QALY) gained) assessed at 45 days after inclusion. Health-related quality of life will be collected using EQ-5D-5L self-administered questionnaires at each scheduled follow-up at 45 days (±/- 5). Resources consumed will be taken from french national Health Data System.
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Study Director: Delphine Douillet, Doctor, Angers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2024

Primary Completion (Estimated)

November 19, 2026

Study Completion (Estimated)

November 19, 2026

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

December 22, 2023

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC21_0376
  • 2023-509905-62-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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