Hemotrial Un proyecto de SEHH

Ensayo clínico

Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism. Rivaroxaban oral, inhibidor directo del factor Xa en pacientes con trombosis venosa profunda o embolia pulmonar agudas sintomáticas.

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Resumen

2017-03-15 04:01:29
2006-004495-13
BAY 59-7939/11702
Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism. Rivaroxaban oral, inhibidor directo del factor Xa en pacientes con trombosis venosa profunda o embolia pulmonar agudas sintomáticas.
BAY 59-7939/11702

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Bayer Healthcare AG Germany

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
rivaroxaban
BAY 59-7939 Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

BAY 59-7939

Concentración del fármaco:

mg milligram(s) equal

15

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Test
rivaroxaban
BAY 59-7939 Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

BAY 59-7939

Concentración del fármaco:

mg milligram(s) equal

20

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 3:
Test
warfarin
acenocoumarol Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 4:
Test
enoxaparin
Solution for injection
Subcutaneous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/ml milligram equal

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
No

No
Si

Information no disponible en EudraCT
No

No
No

Si
  FÁRMACO 5:
Test
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Enfermedad Trombótica

Treatment and secondary prevention of venous thromboembolism in patients with acute symptomatic deep- vein thrombosis or pulmonary embolism


For the Einstein-DVT evaluation. The primary efficacy objective is to evaluate whether rivaroxaban is at least as effective as enoxaparin/VKA in the treatment of patients with acute symptomatic deep-vein thrombosis (DVT) withoutsymptomatic pulmonary embolism (PE) for the prevention of recurrent venous thromboembolic events.For the Einstein-PE evaluation. The primary efficacy objective is to evaluate whether rivaroxaban is at least as effective as enoxaparin/VKA in the treatment of patients with acute symptomatic PE with or without symptomatic DVT for the prevention of recurrent venous thromboembolic events.


No


For Einstein-DVT:confirmed acute symptomatic proximal DVT without symptomatic PE , orFor Einstein-PE:confirmed acute symptomatic PE with or without symptomatic DVT

1. Legal lower age limitations (country specific)2. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE3. Other indication for VKA than DVT and/or PE4. More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW)Heparin/fondaparinux or more than a single dose of VKA prior to randomization5. Participation in another pharmacotherapeutic study within 30 days6. Creatinine clearance < 30 ml/min,7. Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN8. Bacterial endocarditis9. Life expectancy <3 months10. Active bleeding or high risk for bleeding contraindicating treatment withenoxaparin or VKA11. Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg12. Childbearing potential without proper contraceptive measures, pregnancy or breast feeding13. Any other contraindication listed in the local labeling of warfarin,acenocoumarol, or enoxaparin14. Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketokonazole)

The primary efficacy outcome is symptomatic recurrent VTE, i.e., the composite of recurrent DVT or fatal or non-fatal PE occurring during the 3-, 6,- and 12-month study treatment periods.The following definitions are applied by the CIAC to confirm a suspected episode of symptomatic recurrent PE/DVT. (3;4)1. Suspected (recurrent) PE with one of the following findings• a (new) intraluminal filling defect in segmental or more proximal branches on spiral CT scan• a (new) intraluminal filling defect or an extension of an existing defect or a new sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram• a (new) perfusion defect of at least 75% of a segment with a local normalventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)• inconclusive sCT, pulmonary angiography or VPLS with demonstration of DVT in the lower extremities by compression ultrasound or venography.or2. Suspected (recurrent) DVT with one of the following findingsif there were no previous DVT investigations:• abnormal compression ultrasound (CUS)• an intraluminal filling defect on venographyif there was a DVT investigation at screening:• abnormal CUS where compression had been normal or, if non-compressible during screening, a substantial increase (4 mm or more) in diameter of the thrombus during full compression• an extension of an intraluminal filling defect, or a new intraluminal filling defect or an extension of non-visualization of veins in the presence of a suddencut-off on venography3. Fatal PE• PE based on objective diagnostic testing, autopsy, or• death which can not be attributed to a documented cause and for which PE/DVT can not be ruled out (unexplained death).In the absence of objective testing, a suspected episode of DVT or PE will be considered as confirmed if it led to a change in anticoagulant treatment attherapeutic dosages for more than 48 hours.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:


Si
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

2
3
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:


0
1

1

Sexo:


1
1

Número planeado de pacientes a incluir:


120

Para estudios internacionales:


3000
6260

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha