Venous ThromboembolismPhase 3RIVACASTNCT06195540
RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing
A Phase 3 study testing Rivaroxaban 10 MG and Low Heparin Molecular Weight in people with Venous Thromboembolism and Deep Vein Thrombosis, run by University Hospital, Angers at 37 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism
- What is being tested?
- Rivaroxaban 10 MG and Low Heparin Molecular Weight
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,424 participants
- Where
- 37 sitesFrance
- Study dates
- 19 Jul 2024to 19 Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
37 sites in 1 country
France37 sites, 31 recruiting
- Active, not recruiting
Agen-Nerac Hospital, Emergency Department
Agen, 47923
- Recruiting
Angers University Hospital, Emergency department
Angers, 49000
Delphine Douillet, Doctor, 0241353637, Delphine.Douillet@chu-angers.fr
- Recruiting
Argenteuil hospital, Emergency department
Argenteuil, 95100
Catherine Le Gall, Doctor, 0134232425, catherine.legall@ch-argenteuil.fr
- Withdrawn
Arpajon Hospital, Emergency Department
Arpajon, 91294
- Withdrawn
Caen University hospital, Emergency department
Caen, 14000
- Withdrawn
Tours University Hospital, Emergency department
Chambray-lès-Tours, 37170
- Recruiting
Cholet Hospital, Emergency department
Cholet, 49300
Caroline Soulie, Doctor, 0241496985, caroline.soulie-chavignon@ch-cholet.fr
- Recruiting
Clermont-Ferrand University Hospital, Emergency department
Clermont-Ferrand, 63000
Romain Durif, Doctor, 0473751940, rdurif@chu-clermontferrand.fr
- Recruiting
Simone Veil Hospital, Emergency Department
Eaubonne, 95600
Hiba Boussaha, Doctor, 01 34 06 61 15 ext. +33, Hiba.boussaha@ch-simoneveil.fr
- Active, not recruiting
Eure-Seine Hospital, Emergency Departement
Évreux, 27015
- Recruiting
Grenoble University Hospital, Emergency Department
Grenoble, 38000
Damien Viglino, Professor, 0476766784, dviglino@chu-grenoble.fr
- Not yet recruiting
La Roche sur Yon Hospital
La Roche-sur-Yon, 85000
Iona MAITRE, Doctor, 0251446205, iona.maitre@ght85.fr
- Recruiting
La Rochelle Hospital, Adult emergency departement
La Rochelle, 17000
Maxime Jonchier, Doctor, 0546465050, maxime.jonchier@gmail.com
- Recruiting
Le Mans Hospital, Emergency department
Le Mans, 72000
Cyrielle Houalard, Doctor, 0243434343, cyrielle.houalard@gmail.com
- Recruiting
Limoges University hospital, Emergency department
Limoges, 87000
Thomas Lafon, Doctor, 0555056254, thomas.LAFON@chu-limoges.fr
- Recruiting
Edouard Herriot University Hospital, Emergency Department
Lyon, 69000
Karim Tazarourte, Professor, 0472110040, karim.tazarourte@chu-lyon.fr
- Recruiting
Marseille University Hospital, Emergency department
Marseille, 13005
Thibault Markarian, Doctor, 0413429700, thibault.markarian@ap-hm.fr
- Recruiting
Melun Hospital, Emergency Department
Melun, 77000
Damien Herve du Penhoat, Doctor, +33164716000, damien.herve-du-penhoat@ghsif.fr
- Recruiting
Montpellier University Hospital, emergency department
Montpellier, 34000
Mustapha Sebbane, Professor, 0467337974, m-sebbane@chu-montpellier.fr
- Not yet recruiting
Nancy University Hospital, Emergency department
Nancy, 54000
Tahar CHOUIHED, Professor, 0383851496, t.chouihed@chru-nancy.fr
- Recruiting
Nantes University Hospital, Emergency department
Nantes, 44000
François Javaudin, Doctor, 0240083333, Francois.JAVAUDIN@chu-nantes.fr
- Withdrawn
Nice University Hospital, Emergency department
Nice, 06000
- Recruiting
Niort Hospital, Emergency Department
Niort, 79000
Mathieu Violeau, Doctor, 0549783015, mathieu.violeau@ch-niort.fr
- Not yet recruiting
Lariboisière hospital, emergency department
Paris, 75010
Anthony Chauvin, Professor, 0149956565, anthony.chauvin@aphp.fr
- Recruiting
Saint-Antoine Hospital, Emergency department
Paris, 75012
Pierre-Clément Thiebault, Doctor, 0149282743, pierre-clement.thiebaud@aphp.fr
- Not yet recruiting
La Pitié-Salpétrière Hospital, Emergency Department
Paris, 75013
Yonathan Freund, Doctor, 01 42 16 00 00, yonathan.freund@aphp.fr
- Recruiting
Cochin Hospital, Emergency department
Paris, 75014
Florence Dumas, Doctor, 0158412707, florence.dumas@aphp.fr
- Recruiting
St-Joseph Hospital, Emergency Department
Paris, 75014
Camille Gerlier, Doctor, 01 44 12 80 23, cgerlier@ghpsj.fr
- Recruiting
HEGP, Emergency Department
Paris, 75015
Richard Chocron, Doctor, 0156095876, richard.chocron@gmail.com
- Recruiting
Bichat Hospital, Adult Emergency department
Paris, 75018
Donia Bouzid, Doctor, 0140258080, donia.bouzid@aphp.fr
- Recruiting
South Lyon University Hospital, Emergency department
Pierre-Bénite, 69495
Marion Douplat, Doctor, 0478862854, marion.douplat@chu-lyon.fr
- Recruiting
Poitiers University Hospital, Emergency department
Poitiers, 86000
Jérémy Guenezan, Doctor, 0549444444, jeremy.guenezan@chu-poitiers.fr
- Recruiting
Rennes University Hospital, Emergency department
Rennes, 35000
Vincent Levrel, Doctor, 0299284321, Vincent.LEVREL@chu-rennes.fr
- Not yet recruiting
Rouen University Hospital, Emergency Department
Rouen, 76000
Mélanie Roussel, Doctor, 0232881879, melanie.roussel@chu-rouen.fr
- Recruiting
Strasbourg University Hospital, Emergency Department
Strasbourg, 67000
Pierrick Le Borgne, Doctor, 0388128690, pierrick.leborgne@chru-strasbourg.fr
- Recruiting
Toulouse University Hospital, Emergency Department
Toulouse, 31000
Xavier Dubucs, Doctor, 0561775919, xavier.dubucs@gmail.com
- Recruiting
Vannes Hospital, Emergency Department
Vannes, 56000
Bertrand Boulanger, Doctor, +33297014141, bertrand.boulanger@ghba.fr
About this study
Official title: 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.
- Conditions
- Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism, Lower Limb Trauma, Thromboprophylaxis, Immobilisation
- Being tested
- Rivaroxaban 10 MG, Low Heparin Molecular Weight
- Keywords
- Emergency department, direct oral anticoagulant, rivaroxaban, Low-Molecular-weight heparin, randomized control trial, Prevent VTE
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 10 MGDrug
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.
Low Heparin Molecular WeightDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban arm | Experimental | Not described Receives: Drug: Rivaroxaban 10 MG |
| Low-molecular-weight heparin arm | Active comparator | 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). Receives: Drug: Low Heparin Molecular Weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of symptomatic venous thromboembolic events (45 days non-inferiority)
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.
Measured: 45 days
Secondary outcomes (5)
Patient self reported treatment satisfaction
The outcome is patient self-reported treatment satisfaction using the Anti-Clot Treatment Scales (ACTS) assessed at 45 days (+/- 5 days).
Measured: 45 days
Rate of symptomatic venous thromboembolic events (90 days superiority)
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.
Measured: 90 days
Cumulative rates of major bleeding and of non-major clinically relevant bleeding (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.
Measured: 90 days
Incremental cost-utility ratio (rivaroxaban efficiency 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.
Measured: 45 days
Incremental cost-utility ratio (rivaroxaban efficiency 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start19 Jul 2024
- Primary completion19 Nov 2028 (estimated)
- Study completion19 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Delphine Douillet, Doctor, Study director, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195540
- Sponsor's protocol ID
- 49RC21_0376
- Other IDs
- 2023-509905-62-00, 2023
- Acronym
- RIVACAST
- Status last verified
- Jun 2026
- First submitted
- 22 Dec 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIVACAST : RIVAroxaban Versus Low-molecular Weight Heparinin Patients With Lower Limb Trauma Requiring Brace or CASTing
- ClinicalTrials.gov ID
- NCT06195540
- Acronym / sponsor ID
- RIVACAST / 49RC21_0376
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,424 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 19 Nov 2028 (estimated)
- Study completion
- 19 Nov 2028 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban arm | Experimental | Drug: Rivaroxaban 10 MG |
| Low-molecular-weight heparin arm | Active comparator | Drug: Low Heparin Molecular WeightTreatment 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 ;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 10 MGAdministration 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. | Drug | Rivaroxaban arm |
| Low Heparin Molecular WeightAdministration 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. | Drug | Low-molecular-weight heparin arm |
Primary outcome
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.
5 secondary outcomes
Patient self reported treatment satisfaction
Time frame: 45 days
Rate of symptomatic venous thromboembolic events (90 days superiority)
Time frame: 90 days
Cumulative rates of major bleeding and of non-major clinically relevant bleeding (90 days)
Time frame: 90 days
Incremental cost-utility ratio (rivaroxaban efficiency 45 days)
Time frame: 45 days
Incremental cost-utility ratio (rivaroxaban efficiency 90 days)
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Delphine Douillet, Doctor study director
University Hospital, Angers
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban 10 MG and Low Heparin Molecular Weight in people with Venous Thromboembolism and Deep Vein Thrombosis, run by University Hospital, Angers at 37 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delphine Douillet, Doctor (0241353637, Delphine.Douillet@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of symptomatic venous thromboembolic events (45 days non-inferiority) (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.