Hemotrial Un proyecto de SEHH

Ensayo clínico

A SAFETY AND EFFICACY TRIAL EVALUATING THE USE OF APIXABAN FOR THE EXTENDED TREATMENT OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISMENSAYO PARA EVALUAR LA EFICACIA Y SEGURODAD DEL USO DE APIXABAN EN EL TRATAMIENTO AMPLIADO DE LA TROMBOSIS VENOSA PROFUNDA Y LA EMBOLIA PULMONAR Revised Protocol 01 (version 4.0 dated 21-Apr-08), incorporating Amendment 02 (version 1.0 dated 21-Apr-08)+ Protocol Amendment 01 (version 1.0 dated 21-Apr-08) Site-specific - Molecular Profiling Supplement Samples For Pfizer’s Exploratory Research BiobankProtocolo revisado 01 (versión 4.0 de fecha 21-Abril-08). Incorpora la enmienda 02 (versión 1.0 de fecha 21-Abril-08) + Enmienda del protocolo 01 (versión 1.0 de fecha 21-Abril-08)

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Resumen

2017-03-15 04:06:26
2007-004953-27
CV185-057
A SAFETY AND EFFICACY TRIAL EVALUATING THE USE OF APIXABAN FOR THE EXTENDED TREATMENT OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISMENSAYO PARA EVALUAR LA EFICACIA Y SEGURODAD DEL USO DE APIXABAN EN EL TRATAMIENTO AMPLIADO DE LA TROMBOSIS VENOSA PROFUNDA Y LA EMBOLIA PULMONAR Revised Protocol 01 (version 4.0 dated 21-Apr-08), incorporating Amendment 02 (version 1.0 dated 21-Apr-08)+ Protocol Amendment 01 (version 1.0 dated 21-Apr-08) Site-specific - Molecular Profiling Supplement Samples For Pfizer’s Exploratory Research BiobankProtocolo revisado 01 (versión 4.0 de fecha 21-Abril-08). Incorpora la enmienda 02 (versión 1.0 de fecha 21-Abril-08) + Enmienda del protocolo 01 (versión 1.0 de fecha 21-Abril-08)
CV185-057

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Bristol-Myers Squibb International Corporation Belgium

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
Apixaban
BMS-562247-01 Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):
BMS-562247-01 Apixaban

Concentración del fármaco:
mg milligram(s) equal

2.5

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
Apixaban
BMS-562247-01 Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):
BMS-562247-01 Apixaban

Concentración del fármaco:
mg milligram(s) equal

5

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:
  PLACEBO 1:

Si
Film-coated tablet

Oral use
  PLACEBO 2:

Si
Film-coated tablet

Oral use

Información General

Enfermedad Trombótica

Venous Thromboembolism (VTE)Tromboembolismo venoso (TEV)

To determine if at least one of the apixaban dose regimens is superior to placebo in the combined endpoint of symptomatic, recurrent VTE (nonfatal DVT or nonfatal PE) or all-cause death in subjects who have an objectively documented index event of symptomatic proximal DVT or symptomatic PE, have completed approximately 6 to 12 months of standard anticoagulant therapy for the treatment of the index event, and have no objectively documented symptomatic recurrence of VTE after the index event.

To characterize treatment effects of the two apixaban doses relative to placebo for the following:• adjudicated composite of recurrent symptomatic VTE or VTE-related death• adjudicated composite of recurrent symptomatic VTE or CV-related death• adjudicated symptomatic nonfatal DVT• adjudicated symptomatic nonfatal PE• adjudicated VTE-related death• adjudicated CV-related death• all-cause death• adjudicated major bleeding• the adjudicated composite of major bleeding and clinically relevant non-major bleedingTo characterize the primary efficacy outcome in the subset of subjects with index events of DVT only and in the subset of subjects with index events of PE with or without DVT.

No


1) Signed Written Informed Consent2) Target Populationa) Subjects who have:• an objectively documented index event of symptomatic proximal DVT or symptomatic PE; (1) Symptomatic proximal DVT is defined as symptomatic DVT with evidence of thrombosis in a deep vein proximal to (above) the popliteal vein, demonstrated by imaging with compression ultrasound (CUS), including grey-scale or color-coded Doppler, or ascending contrast venography. (2) Symptomatic PE with evidence of thrombosis demonstrated by imaging as follows:? an intraluminal filling defect in segmental or more proximal branches on spiral CT scan; or? an intraluminal filling defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram; or? a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)• completed approximately 6 to 12 months of standard anticoagulant therapy for the treatment of the index event; and• no objectively documented symptomatic recurrence of VTE after the index event.b) Subjects should be randomized within approximately 7 days of the last dose of their initial 6-to 12-month treatment or when their INR is 2 or less, if a VKA was used. Every attempt should be made to randomize subjects as soon as possible after discontinuation of their initial treatment.The index DVT and/or PE will be adjudicated by the ICAC according to the adjudication manual. Investigators are encouraged to assemble and to submit imaging dossiers to the ICAC as soon as possible during the period that extends from the beginning of the screening period up to 2 weeks after randomization. 3) Age and Sexa) Men and women, ages 18 years or greater.Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.

1) Sex and Reproductive Statusa) WOCBP who are unwilling or unable to use an acceptable method of birthcontrol to avoid pregnancy for the entire studyb) Women who are pregnant or breastfeedingc) Women with a positive pregnancy test on enrollment or prior to investigational product administration2) Medical History and Concurrent Diseasesa) Subjects whose index and past DVT(s) and/or PE(s) have all been due solely to a transient (reversible) risk factor (ie, provoked event, eg, secondary to surgery), and who are not expected to have, for 12 months or longer after randomization, persistence of a risk factor (e.g., wheelchair-bound) for DVT and/or PE recurrence.b) More than 12 months of anticoagulation planned for the most recent DVT or PE (index event).c) Subjects with the following indications for long-term treatment with a VKA, such as:• Mechanical valve• Atrial fibrillation or atrial flutter with moderate to high risk of systemic thromboembolism• Multiple episodes of unprovoked DVT or PE• Documented anti-phospholipid antibodies, anti-thrombin III deficiency, protein C deficiency, protein S deficiency, homozygous factor V Leiden, or homozygous prothrombin gene mutation.d) Subjects with cancer who will be treated indefinitely with anticoagulation therapy;e) Serious bleeding prior to randomization (see table under Protocol section 4.2.2 for exact timing of occurence resulting in subject exclusion from the study);f) Active and clinically significant liver disease (eg, hepatorenal syndrome);g) Life expectancy < 12 months;h) Bacterial endocarditis;i) Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg.3) Physical and Laboratory Test Findingsa) Platelet count <100,000/mm3 or hemoglobin <9 g/dLb) Serum creatinine >2.5 mg/dL [221 umol/L] or a calculated creatinine clearance <25 ml/min.c) ALT or AST >2 times upper limit of normal, or a total bilirubin >1.5 times upper limit of normal (unless the latter has an alternative causative factor identified [eg, Gilbert’s syndrome]).4) Prohibited Treatments and/or Therapiesa) Subjects requiring ASA >165 mg/day at randomization.b) Subjects requiring dual anti-platelet therapy (such as ASA plus clopidogrel or ASA plus ticlopidine) at randomization. Subjects who transition from dual anti-platelet therapy to monotherapy prior to randomization will be eligible for the trial.5) Other Exclusion Criteriaa) Prisoners or subjects who are involuntarily incarceratedb) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessc) Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of study treatment (with the exception of approved medications being used for an approved indication, eg, investigating a new dosing regimen for an approved indication);d) Any condition, which in the opinion of the investigator, would put the subject at an unacceptable risk from participating in the study; ore) Any other medical, social, logistical, or psychological reason, which in the opinion of the investigator, would preclude compliance with, or successful completion of, the study protocol

- The primary efficacy outcome is the incidence of an adjudicated composite of recurrent symptomatic VTE (nonfatal DVT and/or nonfatal PE) or all-cause death.- The primary safety outcome is the incidence of adjudicated major bleeding during the treatment period.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
Si

No
No

Si

Centros participantes:

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

2
1
  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:

49

Para estudios internacionales:

735
2430

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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