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

University Hospital, Angers

Status and phase: Enrolling; Phase 3

Conditions: Pulmonary Embolism; Venous Thromboembolism; Deep Vein Thrombosis; Immobilisation; Thromboprophylaxis; Lower Limb Trauma

Treatments: Drug: Rivaroxaban 10 MG; Drug: Low Heparin Molecular Weight

Study type: Interventional

Funder types: Other

Identifiers

NCT06195540

2023-509905-62-00 (EU Trial (CTIS) Number)

49RC21_0376

Details and patient eligibility

About

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.

Enrollment: 1,424 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,424 participants in 2 patient groups

Rivaroxaban arm

Experimental group

Treatment:

Drug: Rivaroxaban 10 MG

Low-molecular-weight heparin arm

Active Comparator group

Description:

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).

Treatment:

Drug: Low Heparin Molecular Weight