Rivaroxaban for Scheduled Work-up of DVT - The Ri-Schedule Study
Deep Venous Thrombosis
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 3
- Rango de edad
- 18 años - 95 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 625 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
This prospective outcome study is designed to assess the safety of rivaroxaban in the pre-diagnosis phase of DVT.
Leer la descripción completa
This prospective outcome study is designed to assess the safety of rivaroxaban in the pre-diagnosis phase of DVT.
International guidelines suggest the use of low molecular weight heparin (LMWH) if the diagnostic process is expected to be delayed for more than 4 hours.
Rivaroxaban is a new DOAC that in clinical trials has proven to be non-inferior to LMWH and warfarin for the treatment of DVT with the added benefit of causing less major bleeding.
Because of its rapid onset of action and oral administration, rivaroxaban could be used instead of LMWH in the pre-diagnosis phase pending the results of the diagnostic test. However, the safety of a such proposed indication has to be proven before it can be adopted in clinical practice.
This study aims to determine the safety and feasibility of pre-diagnostic treatment with rivaroxaban. The primary outcome of this study "safety" is a composite endpoint of serious bleedings encountered within 48 hours after administration of rivaroxaban.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Consecutive outpatients referred to ER because of suspected DVT
- 18 years of age
- Signed informed consent
Exclusion Criteria:
1- refuse to consent
Patients with the criteria below will not be eligible for scheduled work-up:
1. Duration of the diagnostic work-up is expected to last \< 2 hours
2. Presence of active cancer or receiving chemotherapy for cancer
3. Suspicion of coexisting clinical PE
4. Suspicion of active bleeding (gastrointestinal bleeding or muscle hematoma)
5. Signs of threatened circulation or having intractable pain in the lower extremity or may be considered as candidate for thrombolytic treatment
6. Physician does not consider it safe to discharge the patient
7. Presence of logistic factors that may hinder a scheduled work-up
8. Presence of co-morbid conditions that require hospital admission
9. Patient prefers not to be discharged before diagnosis is completed
10. Glomerular Filtration Rate \< 45 ml/min
11. Presence of contraindications to rivaroxaban including;
- Lesion or condition, if considered to be a significant risk for major bleeding e.g current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
- Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban etc.)
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C.
- Pregnancy/positive pregnancy test and breastfeeding (see section 4.6)
11\. Hb \< 11 g/dl 12. Presence of drug interaction with rivaroxaban including concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e.g. ritonavir), acetylsalicylic acid at a dose higher than 160 mg or platelet aggregation inhibitors
Entiende la evaluación inicialTratamiento, grupos y participación
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- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
Rivaroxaban
Rivaroxaban 15 mg every 12 hours until the completion of the diagnostic work-up, which should not exceed 24 hours.
Drug: Rivaroxaban
Rivaroxaban DRUG
Rivaroxaban 15 mg every 12 hours until the completion of the diagnostic work-up, which should not exceed 24 hours (maximum 2 tablets)
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Rate of serious bleedings and/or death related to bleeding
Plazo: Until 48 hours after last tablet
Serious bleedings and/or death related to bleeding encountered within 48 hours after the last rivaroxaban tablet was ingested in patients in whom DVT was excluded or until the ingestion of first tablet of oral anticoagulation or application of IV/SC heparin in those in whom DVT is confirmed.
Medidas secundarias
Feasability rate
Plazo: 12 hours
Assessed by the proportion of patients who can be managed by a scheduled work-up
Failure rate
Plazo: until 48 hours after last tablet
Worsening in pre-existing complaints or developement of signs/symptoms of pulmonary embolism
90-day outcome
Plazo: 90 days
The 90-day outcome of the applied diagnostic strategy using Wells pre-test clinical probability, D-dimer and compression ultrasounography and safety of coagulation
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Ostfold Hospital TrustFredrikstad, Østfold fylke, NorwayEstado desconocido
Equipo y fechas
- Patrocinador principal
- Ostfold Hospital Trust
- Inicio del estudio
- 2015-03 Real
- Finalización primaria
- 30 nov 2018 Real
- Finalización del estudio
- 30 dic 2018 Real
- Primera publicación
- 1 jul 2015 Estimado
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Rivaroxaban for Scheduled Work-up of Patients With Suspected Deep Venous Thrombosis
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026