Clinical trial NCT06195540: RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing
Official title: RIVACAST : RIVAroxaban Versus Low-molecular Weight Heparinin Patients With Lower Limb Trauma Requiring Brace or CASTing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolism
Lower Limb Trauma
Thromboprophylaxis
Immobilisation
Keywords: Emergency department
direct oral anticoagulant
rivaroxaban
Low-Molecular-weight heparin
randomized control trial
Prevent VTE
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-01-08
Enrollment: 1424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of symptomatic venous thromboembolic events (45 days non-inferiority)
timeFrame: 45 days
Secondary outcomes:
measure: Patient self reported treatment satisfaction
timeFrame: 45 days
measure: Rate of symptomatic venous thromboembolic events (90 days superiority)
timeFrame: 90 days
measure: Cumulative rates of major bleeding and of non-major clinically relevant bleeding (90 days)
timeFrame: 90 days
measure: Incremental cost-utility ratio (rivaroxaban efficiency 45 days)
timeFrame: 45 days
measure: Incremental cost-utility ratio (rivaroxaban efficiency 90 days)
timeFrame: 90 days
Other outcomes:
Locations:
city: Agen
country: France
facility: Agen-Nerac Hospital, Emergency Department
city: Angers
country: France
facility: Angers University Hospital, Emergency department
city: Argenteuil
country: France
facility: Argenteuil hospital, Emergency department
city: Arpajon
country: France
facility: Arpajon Hospital, Emergency Department
city: Caen
country: France
facility: Caen University hospital, Emergency department
city: Chambray-lès-Tours
country: France
facility: Tours University Hospital, Emergency department
city: Cholet
country: France
facility: Cholet Hospital, Emergency department
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital, Emergency department
city: Eaubonne
country: France
facility: Simone Veil Hospital, Emergency Department
city: Evreux
country: France
facility: Eure-Seine Hospital, Emergency Departement
city: Grenoble
country: France
facility: Grenoble University Hospital, Emergency Department
city: La Rochelle
country: France
facility: La Rochelle Hospital, Adult emergency departement
city: Le Mans
country: France
facility: Le Mans Hospital, Emergency department
city: Limoges
country: France
facility: Limoges University hospital, Emergency department
city: Lyon
country: France
facility: Edouard Herriot University Hospital, Emergency Department
city: Marseille
country: France
facility: Marseille University Hospital, Emergency department
city: Montpellier
country: France
facility: Montpellier University Hospital, emergency department
city: Nantes
country: France
facility: Nantes University Hospital, Emergency department
city: Nice
country: France
facility: Nice University Hospital, Emergency department
city: Niort
country: France
facility: Niort Hospital, Emergency Department
city: Paris
country: France
facility: Lariboisière hospital, emergency department
city: Paris
country: France
facility: Saint-Antoine Hospital, Emergency department
city: Paris
country: France
facility: La Pitié-Salpétrière Hospital, Emergency Department
city: Paris
country: France
facility: Cochin Hospital, Emergency department
city: Paris
country: France
facility: St-Joseph Hospital, Emergency Department
city: Paris
country: France
facility: HEGP, Emergency Department
city: Paris
country: France
facility: Bichat Hospital, Adult Emergency department
city: Pierre-Bénite
country: France
facility: South Lyon University Hospital, Emergency department
city: Poitiers
country: France
facility: Poitiers University Hospital, Emergency department
city: Rennes
country: France
facility: Rennes University Hospital, Emergency department
city: Rouen
country: France
facility: Rouen University Hospital, Emergency Department
city: Strasbourg
country: France
facility: Strasbourg University Hospital, Emergency Department
city: Toulouse
country: France
facility: Toulouse University Hospital, Emergency Department
Study officials:
affiliation: Angers University Hospital
name: Delphine Douillet, Doctor
role: STUDY_DIRECTOR
References: