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Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement

22 de abril de 2014 actualizado por: Boehringer Ingelheim

A Phase III, Randomized, Parallel-group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens (75mg Day 1 Followed by 150 mg Day 2-completion, and 110 mg Day 1 Followed by 220 mg Day 2-completion) of Dabigatran Etexilate Administered Orally (Capsules), Compared to Enoxaparin 30 mg Twice a Day Subcutaneous for 12 - 15 Days in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery

To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

2615

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá
        • 1160.24.02031 University of Alberta Hospital
      • Edmonton, Alberta, Canadá
        • 1160.24.02036 2B2.37 Walter Mackenizie Centre
      • Red Deer, Alberta, Canadá
        • 1160.24.02024 Red Deer Regional Hospital
    • British Columbia
      • Kelowna, British Columbia, Canadá
        • 1160.24.02032 Kelowna General Hospital
      • Vancouver, British Columbia, Canadá
        • 1160.24.02034 Hematology/Oncology Research
    • Manitoba
      • Winnipeg, Manitoba, Canadá
        • 1160.24.02025 Grace General Hospital
    • New Brunswick
      • Fredericton, New Brunswick, Canadá
        • 1160.24.02007 Orthopaedics 4NE
      • Saint John, New Brunswick, Canadá
        • 1160.24.02027 Atlantic Health Sciences Corporation
    • Ontario
      • Ajax, Ontario, Canadá
        • 1160.24.02021 Rouge Valley Health System
      • Barrie, Ontario, Canadá
        • 1160.24.02008 Orthopaedic Surgery
      • Brantford, Ontario, Canadá
        • 1160.24.02016 Orthopaedic Surgery
      • Burlington, Ontario, Canadá
        • 1160.24.02010 Joseph Brant Memorial Hospital
      • Guelph, Ontario, Canadá
        • 1160.24.02001 73 Delhi Street
      • Hamilton, Ontario, Canadá
        • 1160.24.02014 565 Sanatorium Road
      • Kitchener, Ontario, Canadá
        • 1160.24.02004 Grand River Hospital
      • Niagara Falls, Ontario, Canadá
        • 1160.24.02028 NHS- Greater Niagara General Site
      • Oshawa, Ontario, Canadá
        • 1160.24.02022 Lakeridge Health Oshawa
      • Ottawa, Ontario, Canadá
        • 1160.24.02017 1053 Carling Avenue
      • Ottawa, Ontario, Canadá
        • 1160.24.02026 Ottawa Hospital - General Campus
      • Richmond Hill, Ontario, Canadá
        • 1160.24.02015 York Central Hospital Research
      • Scarborough, Ontario, Canadá
        • 1160.24.02009 2863 Ellesmere Road
      • St. Catherine's, Ontario, Canadá
        • 1160.24.02029 Niagara Health System St. Catharine's General Site
      • Stratford, Ontario, Canadá
        • 1160.24.02003 46 General Hospital Drive
      • Thunder Bay, Ontario, Canadá
        • 1160.24.02033 Thunder Bay Regional Hospital
      • Toronto, Ontario, Canadá
        • 1160.24.02002 Toronto East General Hospital Fracture Clinic
      • Toronto, Ontario, Canadá
        • 1160.24.02023 North York General Hospital
      • Toronto, Ontario, Canadá
        • 1160.24.02030 St. Joseph's Health Centre
      • Welland, Ontario, Canadá
        • 1160.24.02006 206-477 King Street
      • Weston, Ontario, Canadá
        • 1160.24.02035 Humber River Regional Hospital
      • Windsor, Ontario, Canadá
        • 1160.24.02011 Windsor Regional Hospital
      • Windsor, Ontario, Canadá
        • 1160.24.02012 Hotel Dieu Grace Hospital
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canadá
        • 1160.24.02013 Queen Elizabeth Hospital
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos
        • 1160.24.01074 Capstone Clinical Trials, Inc.
      • Northport, Alabama, Estados Unidos
        • 1160.24.01079 West AL Research, Inc
    • Arizona
      • Tucson, Arizona, Estados Unidos
        • 1160.24.01047 Tucson Orhtopaedic Institute
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos
        • 1160.24.01025 Martin, Bowen, Hefley Knee and Sports
      • Little Rock, Arkansas, Estados Unidos
        • 1160.24.01053 OrthoArkansas, PA
      • Little Rock, Arkansas, Estados Unidos
        • 1160.24.01085 Martin, Bowen, Hefley Knee and Sports
    • California
      • Encinitas, California, Estados Unidos
        • 1160.24.01041 Core Orthopedic Medical Center
      • Glendale, California, Estados Unidos
        • 1160.24.01034 Glendale Adventist Medical Center
      • La Jolla, California, Estados Unidos
        • 1160.24.01005 Scripps Clinical Ctr for Orthopedic Rsrch & Educ
      • Long Beach, California, Estados Unidos
        • 1160.24.01077 Long Beach VA Healthcare system
      • Orange, California, Estados Unidos
        • 1160.24.01064 Orthopedic Specialty Institute
    • Colorado
      • Aurora, Colorado, Estados Unidos
        • 1160.24.01031 Colorodo Orthopedic Consultants, PC
      • Denver, Colorado, Estados Unidos
        • 1160.24.01027 Advanced Orthopedic and Sports Medicine Specialists, PC
      • Engelwood, Colorado, Estados Unidos
        • 1160.24.01023 Orthopedic Physicians of Colorado, PC
    • Florida
      • Bay Pines, Florida, Estados Unidos
        • 1160.24.01020 Bay Pines VA Medical Center
      • Brandon, Florida, Estados Unidos
        • 1160.24.01024 Pulmonary Associates of Brandon Clinical Research
      • Clearwater, Florida, Estados Unidos
        • 1160.24.01030 Alliance Research, Inc.
      • Deland, Florida, Estados Unidos
        • 1160.24.01039 Florida Orthopedic Associates
      • Hollywood, Florida, Estados Unidos
        • 1160.24.01036 Orthopaedic Associates of South Broward, PA
      • Melbourne, Florida, Estados Unidos
        • 1160.24.01010 MIMA Century Research Associates
      • Miami, Florida, Estados Unidos
        • 1160.24.01062 Miami Institute for Joint Reconstruction
      • Orlando, Florida, Estados Unidos
        • 1160.24.01040 Southern Clinical Research Consultants
      • Pensacola, Florida, Estados Unidos
        • 1160.24.01067 Baptist Clinical Research
      • Pinellas Park, Florida, Estados Unidos
        • 1160.24.01001 Boehringer Ingelheim Investigational Site
      • Pinellas Park, Florida, Estados Unidos
        • 1160.24.01017 Boehringer Ingelheim Investigational Site
      • Pinellas Park, Florida, Estados Unidos
        • 1160.24.01019 Boehringer Ingelheim Investigational Site
      • Port Orange, Florida, Estados Unidos
        • 1160.24.01029 Coastal Medical Research
      • Tampa, Florida, Estados Unidos
        • 1160.24.01038 James A. Haley VA Hospital
    • Georgia
      • Atlanta, Georgia, Estados Unidos
        • 1160.24.01063 Resurgens Orthopaedics
      • Atlanta, Georgia, Estados Unidos
        • 1160.24.01072 Resurgeons Orthopedics
      • Lawrencville, Georgia, Estados Unidos
        • 1160.24.01056 Southern Orthopaedic Specialists
    • Idaho
      • Boise, Idaho, Estados Unidos
        • 1160.24.01028 Intermountain Research Center
    • Iowa
      • Des Moines, Iowa, Estados Unidos
        • 1160.24.01022 Iowa Orthopedic Clinic
    • Kentucky
      • Lexington, Kentucky, Estados Unidos
        • 1160.24.01008 Bluegrass Orthopedic/Musculoskeletal Research, LLC
    • Maryland
      • Baltimore, Maryland, Estados Unidos
        • 1160.24.01070 Sinai Hospital of Baltimore
      • Towson, Maryland, Estados Unidos
        • 1160.24.01007 Ortho Associates
    • Missouri
      • Kansas City, Missouri, Estados Unidos
        • 1160.24.01059 Rockhill Orthopaedics
    • Montana
      • Missoula, Montana, Estados Unidos
        • 1160.24.01042 Center for Joint Care
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos
        • 1160.24.01014 Charlotte Orthopedic Specialists
    • Ohio
      • Cincinnati, Ohio, Estados Unidos
        • 1160.24.01035 Wellington Orthopedics and Sports Medicine
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos
        • 1160.24.01006 VA Medical Center
      • Tulsa, Oklahoma, Estados Unidos
        • 1160.24.01044 Tulsa Bone and Joint Associates
    • Oregon
      • Bend, Oregon, Estados Unidos
        • 1160.24.01002 The Orthopedic and Neurological Center of the Cascades
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos
        • 1160.24.01046 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston, South Carolina, Estados Unidos
        • 1160.24.01016
      • Conway, South Carolina, Estados Unidos
        • 1160.24.01073 Coastal Orthopedic Associates, PA
    • Texas
      • Austin, Texas, Estados Unidos
        • 1160.24.01032 Seton Medical Center
      • Dallas, Texas, Estados Unidos
        • 1160.24.01003 Texas Orthopedic Associates
      • Dallas, Texas, Estados Unidos
        • 1160.24.01090 VA Medical Center
      • Houston, Texas, Estados Unidos
        • 1160.24.01026 James Muntz, MD
      • Houston, Texas, Estados Unidos
        • 1160.24.01033 Bone and Joint Clinic of Houston
      • Houston, Texas, Estados Unidos
        • 1160.24.01076 Discovery Alliance
      • Lubbock, Texas, Estados Unidos
        • 1160.24.01018 Gill Research Center
      • Plano, Texas, Estados Unidos
        • 1160.24.01069 Correspondence and Pateint vists
      • San Antonio, Texas, Estados Unidos
        • 1160.24.01015 Unlimited Research, LP
    • Virginia
      • Alexandria, Virginia, Estados Unidos
        • 1160.24.01012 Anderson Orthopedic Clinic
    • Washington
      • Seattle, Washington, Estados Unidos
        • 1160.24.01052 Swedish Medical Center
      • Spokane, Washington, Estados Unidos
        • 1160.24.01057 Orthopedic Specialty Clinic of Spokane, PLLC
      • Tacoma, Washington, Estados Unidos
        • 1160.24.01082 MultiCare Health System
  • México
      • Guadalajara, Jalisco, México
        • 1160.24.05009 Traumatologia, Planta Baja
      • México, México
        • 1160.24.05004
  • Reino Unido
      • London, Reino Unido
        • 1160.24.44001 Ravenscourt Park Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion criteria INCLUSION CRITERIA

  1. Patients scheduled to undergo a primary, unilateral elective total knee repla cement.
  2. Male or female 18 years of age or older.
  3. Patients weighing at least 40 kg.
  4. Written informed consent prior to the start of study participation.

Exclusion criteria EXCLUSION CRITERIA

  1. History of bleeding diathesis.
  2. Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding.
  3. Major surgery or trauma (e.g. hip fracture) within the last 3 months.
  4. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months.

  5. Spinal or epidural anesthesia, for which more than 3 attempts (sticks) at placement were made, or the placement was traumatic.

    Please note that patients, who are not excluded under this criterion, are to have the catheter pulled at the completion of surgery.

  6. Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm.
  7. History of VTE or pre-existing condition requiring anticoagulant therapy.
  8. Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months.
  9. Gastric or duodenal ulcer within the last 6 months.
  10. Liver disease expected to have any potential impact on survival (e.g. hepatitis B or C, cirrhosis, but not Gilbert's syndrome or hepatitis A with complete recovery).
  11. Elevated AST or ALT >2x upper limit of normal, based on central lab results or local lab results within 1 month before enrollment.
  12. Known severe renal insufficiency (CrCl < 30 mL/min). In order to determine patient inclusion/exclusion, creatinine clearance (CrCl) needs to be calculated only if serum creatinine is elevated or renal insufficiency is suspected.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Dabigatran Dose 1
low dose regimen taken once daily
Droga: Dabigatran Dose 1 - day 2 to completion
low dose regimen taken once daily
Droga: Dabigatran Dose 1 - day 1
low dose regimen taken once daily
Experimental: Dabigatran Dose 2
high dose regimen taken once daily
Droga: Dabigatran Dose 2 - day 2 to completion
high dose regimen taken once daily
Droga: Dabigatran Dose 2 - day 1
high dose regimen taken once daily
Comparador activo: Enoxaparin
30 mg subcutaneously twice daily
Droga: Enoxaparin
30 mg subcutaneously twice daily

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Periodo de tiempo: First administration until 12-15 days

Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).

All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.
First administration until 12-15 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Periodo de tiempo: First administration until 12-15 days
Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
First administration until 12-15 days
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
Periodo de tiempo: First administration until 12-15 days
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
First administration until 12-15 days
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
Periodo de tiempo: First administration until 12-15 days
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
First administration until 12-15 days
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
Periodo de tiempo: First administration until 12-15 days
Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
First administration until 12-15 days
Number of Participants With Pulmonary Embolism During Treatment Period
Periodo de tiempo: First administration until 12-15 days
Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee
First administration until 12-15 days
Number of Participants Who Died During Treatment Period
Periodo de tiempo: First administration until 12-15 days
All cause death, as adjudicated by the VTE events committee
First administration until 12-15 days
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
Periodo de tiempo: 3 months
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
3 months
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
Periodo de tiempo: First administration until 12-15 days

Major bleeding events were defined as

  • fatal
  • clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected
  • clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
  • symptomatic retroperitoneal, intracranial, intraocular or intraspinal
  • requiring treatment cessation
  • leading to re-operation

Clinically-relevant was defined as

  • spontaneous skin hematoma greater than or equal to 25 cm²
  • wound hematoma greater than or equal to 100 cm²
  • spontaneous nose bleed lasting longer than 5 min
  • macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
  • spontaneous rectal bleeding (more than a spot on toilet paper)
  • gingival bleeding lasting longer than 5 min
  • any other bleeding event considered clinically relevant by the investigator

Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
First administration until 12-15 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Boehringer Ingelheim

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de noviembre de 2004

Finalización primaria (Actual)

1 de junio de 2006

Finalización del estudio

7 de diciembre de 2022

Fechas de registro del estudio

Enviado por primera vez

8 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

8 de septiembre de 2005

Publicado por primera vez (Estimar)

12 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

5 de mayo de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

22 de abril de 2014

Última verificación

1 de abril de 2014

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1160.24

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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