NCT06195540 RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing
| NCT ID | NCT06195540 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Angers |
| Condition | Venous Thromboembolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,424 participants |
| Start Date | 2024-07-19 |
| Primary Completion | 2028-11-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,424 participants in total. It began in 2024-07-19 with a primary completion date of 2028-11-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Delphine Douillet, Doctor
STUDY DIRECTOR
University Hospital, Angers
Frequently Asked Questions
Who can join the NCT06195540 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Thromboembolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06195540 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,424 participants.
Is NCT06195540 currently recruiting?
Yes, NCT06195540 is actively recruiting participants. Contact the research team at Delphine.Douillet@chu-angers.fr for enrollment information.
Where is the NCT06195540 trial being conducted?
This trial is being conducted at Agen, France, Angers, France, Argenteuil, France, Arpajon, France and 11 additional locations.
Who is sponsoring the NCT06195540 clinical trial?
NCT06195540 is sponsored by University Hospital, Angers. The principal investigator is Delphine Douillet, Doctor at University Hospital, Angers. The trial plans to enroll 1,424 participants.