Clinical trial • Phase III • Musculoskeletal|Cardiology

RIVAROXABAN for Lower limb trauma

Phase III trial of RIVAROXABAN for Lower limb trauma.

Overview

Trial Therapeutic Area
Musculoskeletal|Cardiology
Trial Disease
Lower limb trauma
Trial Stage
Phase III
Drug Modality
Small molecule|Other

Key dates

Initial CTIS Submission Date
22-12-2023
First CTIS Authorization Date
12-04-2024

Trial design

FRAGMINE 5 000 U.l. anti Xa/0,2 mL, solution injectable en seringue pré-remplie (dalteparin sodium) - subcutaneous injection; INNOHEP 4 500 UI anti-Xa/0,45 ml, solution injectable en seringue préremplie (tinzaparin sodium) - subcutaneous injection; Inhixa 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringe (enoxaparin sodium) - subcutaneous injection; LOVENOX 4 000 UI (40 mg)/0,4 ml, solution injectable en seringue préremplie (enoxaparin sodium) - subcutaneous injection; FRAXIPARINE 3 800 U.I. Axa/0,4 ml, solution injectable (S.C.) en seringue pré-remplie (nadroparin calcium) - subcutaneous injection; FRAXIPARINE 5 700 U.I. Axa/0,6 ml, solution injectable (S.C.) en seringue pré-remplie (nadroparin calcium) - subcutaneous injection; FRAGMINE 2 500 U.l. anti Xa/0,2 mL, solution injectable en seringue pré-remplie (dalteparin sodium) - subcutaneous injection-controlled Phase III trial in France.

Comparator
FRAGMINE 5 000 U.l. anti Xa/0,2 mL, solution injectable en seringue pré-remplie (dalteparin sodium) - subcutaneous injection; INNOHEP 4 500 UI anti-Xa/0,45 ml, solution injectable en seringue préremplie (tinzaparin sodium) - subcutaneous injection; Inhixa 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringe (enoxaparin sodium) - subcutaneous injection; LOVENOX 4 000 UI (40 mg)/0,4 ml, solution injectable en seringue préremplie (enoxaparin sodium) - subcutaneous injection; FRAXIPARINE 3 800 U.I. Axa/0,4 ml, solution injectable (S.C.) en seringue pré-remplie (nadroparin calcium) - subcutaneous injection; FRAXIPARINE 5 700 U.I. Axa/0,6 ml, solution injectable (S.C.) en seringue pré-remplie (nadroparin calcium) - subcutaneous injection; FRAGMINE 2 500 U.l. anti Xa/0,2 mL, solution injectable en seringue pré-remplie (dalteparin sodium) - subcutaneous injection
Target Sample Size
1424
Trial Duration For Participant
90

Eligibility

Recruits 1424 No vulnerable populations selected. Participants must be aged ≥ 18 years and provide signed and dated free informed consent..

Pregnancy Exclusion
Pregnant or breastfeeding woman
Vulnerable Population
No vulnerable populations selected. Participants must be aged ≥ 18 years and provide signed and dated free informed consent.

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years"}
  • {"criterion_text":"- Consultation in one of the Emergency Departments of the participating centres"}
  • {"criterion_text":"- Lower limb injury requiring rigid or semi-rigid orthopaedic immobilisation"}
  • {"criterion_text":"- Intended duration of orthopaedic immobilisation of 2 weeks or more"}
  • {"criterion_text":"- TRiP(cast) score ≥ 7"}
  • {"criterion_text":"- Full insurance cover"}
  • {"criterion_text":"- Signed and dated free informed consent"}

Exclusion criteria

  • {"criterion_text":"- Active bleeding or high risk of bleeding"}
  • {"criterion_text":"- Contra-indication to Rivaroxaban or LMWH"}
  • {"criterion_text":"- Any anticoagulant or antiplatelet treatment prior to trauma (only antiaggregant treatment authorized: aspirin < 325mg/day)"}
  • {"criterion_text":"- Pregnant or breastfeeding woman"}
  • {"criterion_text":"- Factors rendering 3-month follow-up impossible"}
  • {"criterion_text":"- Participation in any interventional study which modifies patient care or could influence study evaluation criteria"}
  • {"criterion_text":"- Patient requiring hospitalization following emergency for a reason other than lower limb trauma"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint is the rate of symptomatic venous thromboembolic events (i.e., deep venous thrombosis and/or pulmonary embolism and/or death due to pulmonary embolism) within the 45 days after the inclusion","definition_or_measurement_approach":"Rate of symptomatic venous thromboembolic events (deep venous thrombosis and/or pulmonary embolism and/or death due to pulmonary embolism) assessed within 45 days after inclusion"}

Recruitment

Planned Sample Size
1424
Recruitment Window Months
27
Consent Approach
Signed and dated free informed consent is required from participants (adults only, age ≥ 18 years). Subject information and informed consent form documents are provided (adult ICF listed in documents).

Methods

  • Recruitment at Emergency Departments of participating centres (patients seen in EDs of participating hospitals in France).

Geography

Total Number Of Sites
35
Total Number Of Participants
1424

France

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
740
Number Of Sites
35
Number Of Participants
1424

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Département de Médecine d'urgence - SAMU34
Contact Person Name
Mustapha SEBBANE
Contact Person Email
m-sebbane@chu-montpellier.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Département d'urgences
Contact Person Name
Thomas LAFON
Contact Person Email
thomas.LAFON@chu-limoges.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'accueil des urgences
Contact Person Name
Pierre-Clément THIEBAUT
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Département de Médecine d'Urgence
Contact Person Name
Delphine DOUILLET
Site Name
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Department Name
Urgences Générales Adultes
Contact Person Name
Maxime JONCHIER
Contact Person Email
maxime.jonchier@gmail.com
Site Name
Centre Hospitalier De Niort
Department Name
Service des urgences SAMU SMUR
Contact Person Name
Elodie ABGUILLERM
Contact Person Email
abgelodie@gmail.com
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service des Urgences Adultes
Contact Person Name
Donia BOUZID
Contact Person Email
donia.bouzid@aphp.fr
Site Name
Centre Hospitalier Eure-Seine
Department Name
Service des Urgences - Unité Urgences Adultes
Contact Person Name
Lucie GAROT
Contact Person Email
lucie.Garot@ch-eureseine.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Urgences adultes
Contact Person Name
Damien VIGLINO
Contact Person Email
dviglino@chu-grenoble.fr
Site Name
Hospices Civils De Lyon
Department Name
Service d'accueil des urgences
Contact Person Name
Marion DOUPLAT
Contact Person Email
marion.douplat@chu-lyon.fr
Site Name
Centre Hospitalier Le Mans
Department Name
Médecine d'Urgences
Contact Person Name
Cyrielle HOUALARD
Contact Person Email
cyrielle.houalard@gmail.com
Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
Service des urgences adultes
Contact Person Name
Camille GERLIER
Contact Person Email
cgerlier@ghpsj.fr
Site Name
Centre Hospitalier General D'Arpajon
Department Name
Département de médecine d'urgence
Contact Person Name
François-Xavier LABORNE
Contact Person Email
fxlaborne@gmail.com
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Urgences adultes
Contact Person Name
Thomas MOUMNEH
Contact Person Email
moumneh_thomas@hotmail.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Urgences adultes
Contact Person Name
Pierrick LE BORGNE
Site Name
Centre Hospitalier Victor Dupouy
Department Name
Service d'Urgence
Contact Person Name
Catherine LE GALL
Contact Person Email
crc@ch-argenteuil.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'accueil des urgences
Contact Person Name
Florence DUMAS
Contact Person Email
florence.dumas@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Département de médecine d'Urgences
Contact Person Name
Céline OCCELLI
Contact Person Email
occelli.c@chu-nice.fr
Site Name
CHU De Rouen
Department Name
Urgences adultes
Contact Person Name
Mélanie ROUSSEL
Contact Person Email
melanie.roussel@chu-rouen.fr
Site Name
Hospices Civils De Lyon
Department Name
Service d'accueil des urgences
Contact Person Name
Karim TAZAROURTE
Contact Person Email
karim.tazarourte@chu-lyon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'accueil des urgences
Contact Person Name
Karine ALAME
Contact Person Email
alame.karine@gmail.com
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Urgences – SAMU – SMUR 86
Contact Person Name
Jérémy GUENEZAN
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'accueil des urgences
Contact Person Name
Richard CHOCRON
Contact Person Email
richard.chocron@gmail.com
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Service de Médecine d'Urgence
Contact Person Name
Richard MACREZ
Contact Person Email
macrez-r@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service d'urgences
Contact Person Name
François JAVAUDIN
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Service d'accueil des urgences
Contact Person Name
Romain DURIF
Contact Person Email
rdurif@chu-clermontferrand.fr
Site Name
Groupe Hospitalier Du Sud Ile De France
Department Name
Urgences
Contact Person Name
Damien HERVE DU PENHOAT
Site Name
Groupement Hospitalier Eaubonne Montmorency Simone Veil
Department Name
Service Urgences Adultes
Contact Person Name
Hiba BOUSSAHA
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service des urgences
Contact Person Name
Vincent LEVREL
Contact Person Email
Vincent.LEVREL@chu-rennes.fr
Site Name
Centre Hospitalier Agen-Nerac
Department Name
Service des urgences
Contact Person Name
Maé ADRIAN
Contact Person Email
adrianm@ch-agen-nerac.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service d'Urgences
Contact Person Name
Thibaut MARKARIAN
Contact Person Email
thibaut.markarian@ap-hm.fr
Site Name
Centre Hospitalier Bretagne Atlantique
Department Name
Service SAMU 56 et Urgences
Contact Person Name
Bertrand BOULANGER
Contact Person Email
bertrand.boulanger@ghba.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'accueil des urgences
Contact Person Name
Anthony CHAUVIN
Contact Person Email
anthony.chauvin@aphp.fr
Site Name
Centre Hospitalier De Cholet
Department Name
Service d'Urgence
Contact Person Name
Caroline SOULIE
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Pôle Médecine d’Urgence
Contact Person Name
Frederic BALEN
Contact Person Email
balen.f@chu-toulouse.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire D'Angers
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Third parties

  • {"country":"France","full_name":"French Ministry of Health","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
Xarelto 10 mg film-coated tablets
Active Substance
RIVAROXABAN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Starting Dose
10 mg
Maximum Dose
10 mg
Investigational Product Name
FRAGMINE 5 000 U.l. anti Xa/0,2 mL, solution injectable en seringue pré-remplie
Active Substance
DALTEPARIN SODIUM
Modality
Other
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised
Starting Dose
5000 anti-Xa IU
Maximum Dose
5000 anti-Xa IU
Investigational Product Name
INNOHEP 4 500 UI anti-Xa/0,45 ml, solution injectable en seringue préremplie
Active Substance
TINZAPARIN SODIUM
Modality
Other
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised
Starting Dose
4500 anti-Xa IU
Maximum Dose
4500 anti-Xa IU
Investigational Product Name
FRAXIPARINE 5 700 U.I. Axa/0,6 ml, solution injectable (S.C.) en seringue pré-remplie
Active Substance
NADROPARIN CALCIUM
Modality
Other
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised
Starting Dose
5700 anti-Xa IU
Maximum Dose
5700 anti-Xa IU
Investigational Product Name
FRAGMINE 2 500 U.l. anti Xa/0,2 mL, solution injectable en seringue pré-remplie
Active Substance
DALTEPARIN SODIUM
Modality
Other
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised
Starting Dose
2500 anti-Xa IU
Maximum Dose
2500 anti-Xa IU
Investigational Product Name
Inhixa 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringe
Active Substance
ENOXAPARIN SODIUM
Modality
Other
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised
Starting Dose
4000 anti-Xa IU (40 mg)
Maximum Dose
4000 anti-Xa IU (40 mg)
Investigational Product Name
LOVENOX 4 000 UI (40 mg)/0,4 ml, solution injectable en seringue préremplie
Active Substance
ENOXAPARIN SODIUM
Modality
Other
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised
Starting Dose
4000 anti-Xa IU (40 mg)
Maximum Dose
4000 anti-Xa IU (40 mg)
Investigational Product Name
FRAXIPARINE 3 800 U.I. Axa/0,4 ml, solution injectable (S.C.) en seringue pré-remplie
Active Substance
NADROPARIN CALCIUM
Modality
Other
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised
Starting Dose
3800 anti-Xa IU
Maximum Dose
3800 anti-Xa IU

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