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

22 aprile 2014 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2615

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Sperimentale: 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
Comparatore attivo: Enoxaparin
30 mg subcutaneously twice daily
Droga: Enoxaparin
30 mg subcutaneously twice daily

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2004

Completamento primario (Effettivo)

1 giugno 2006

Completamento dello studio

7 dicembre 2022

Date di iscrizione allo studio

Primo inviato

8 settembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

8 settembre 2005

Primo Inserito (Stima)

12 settembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

5 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 aprile 2014

Ultimo verificato

1 aprile 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1160.24

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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