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

22. april 2014 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2615

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige
        • 1160.24.44001 Ravenscourt Park Hospital
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
        • 1160.24.01074 Capstone Clinical Trials, Inc.
      • Northport, Alabama, Forenede Stater
        • 1160.24.01079 West AL Research, Inc
    • Arizona
      • Tucson, Arizona, Forenede Stater
        • 1160.24.01047 Tucson Orhtopaedic Institute
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater
        • 1160.24.01025 Martin, Bowen, Hefley Knee and Sports
      • Little Rock, Arkansas, Forenede Stater
        • 1160.24.01053 OrthoArkansas, PA
      • Little Rock, Arkansas, Forenede Stater
        • 1160.24.01085 Martin, Bowen, Hefley Knee and Sports
    • California
      • Encinitas, California, Forenede Stater
        • 1160.24.01041 Core Orthopedic Medical Center
      • Glendale, California, Forenede Stater
        • 1160.24.01034 Glendale Adventist Medical Center
      • La Jolla, California, Forenede Stater
        • 1160.24.01005 Scripps Clinical Ctr for Orthopedic Rsrch & Educ
      • Long Beach, California, Forenede Stater
        • 1160.24.01077 Long Beach VA Healthcare system
      • Orange, California, Forenede Stater
        • 1160.24.01064 Orthopedic Specialty Institute
    • Colorado
      • Aurora, Colorado, Forenede Stater
        • 1160.24.01031 Colorodo Orthopedic Consultants, PC
      • Denver, Colorado, Forenede Stater
        • 1160.24.01027 Advanced Orthopedic and Sports Medicine Specialists, PC
      • Engelwood, Colorado, Forenede Stater
        • 1160.24.01023 Orthopedic Physicians of Colorado, PC
    • Florida
      • Bay Pines, Florida, Forenede Stater
        • 1160.24.01020 Bay Pines VA Medical Center
      • Brandon, Florida, Forenede Stater
        • 1160.24.01024 Pulmonary Associates of Brandon Clinical Research
      • Clearwater, Florida, Forenede Stater
        • 1160.24.01030 Alliance Research, Inc.
      • Deland, Florida, Forenede Stater
        • 1160.24.01039 Florida Orthopedic Associates
      • Hollywood, Florida, Forenede Stater
        • 1160.24.01036 Orthopaedic Associates of South Broward, PA
      • Melbourne, Florida, Forenede Stater
        • 1160.24.01010 MIMA Century Research Associates
      • Miami, Florida, Forenede Stater
        • 1160.24.01062 Miami Institute for Joint Reconstruction
      • Orlando, Florida, Forenede Stater
        • 1160.24.01040 Southern Clinical Research Consultants
      • Pensacola, Florida, Forenede Stater
        • 1160.24.01067 Baptist Clinical Research
      • Pinellas Park, Florida, Forenede Stater
        • 1160.24.01001 Boehringer Ingelheim Investigational Site
      • Pinellas Park, Florida, Forenede Stater
        • 1160.24.01017 Boehringer Ingelheim Investigational Site
      • Pinellas Park, Florida, Forenede Stater
        • 1160.24.01019 Boehringer Ingelheim Investigational Site
      • Port Orange, Florida, Forenede Stater
        • 1160.24.01029 Coastal Medical Research
      • Tampa, Florida, Forenede Stater
        • 1160.24.01038 James A. Haley VA Hospital
    • Georgia
      • Atlanta, Georgia, Forenede Stater
        • 1160.24.01063 Resurgens Orthopaedics
      • Atlanta, Georgia, Forenede Stater
        • 1160.24.01072 Resurgeons Orthopedics
      • Lawrencville, Georgia, Forenede Stater
        • 1160.24.01056 Southern Orthopaedic Specialists
    • Idaho
      • Boise, Idaho, Forenede Stater
        • 1160.24.01028 Intermountain Research Center
    • Iowa
      • Des Moines, Iowa, Forenede Stater
        • 1160.24.01022 Iowa Orthopedic Clinic
    • Kentucky
      • Lexington, Kentucky, Forenede Stater
        • 1160.24.01008 Bluegrass Orthopedic/Musculoskeletal Research, LLC
    • Maryland
      • Baltimore, Maryland, Forenede Stater
        • 1160.24.01070 Sinai Hospital of Baltimore
      • Towson, Maryland, Forenede Stater
        • 1160.24.01007 Ortho Associates
    • Missouri
      • Kansas City, Missouri, Forenede Stater
        • 1160.24.01059 Rockhill Orthopaedics
    • Montana
      • Missoula, Montana, Forenede Stater
        • 1160.24.01042 Center for Joint Care
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater
        • 1160.24.01014 Charlotte Orthopedic Specialists
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
        • 1160.24.01035 Wellington Orthopedics and Sports Medicine
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
        • 1160.24.01006 VA Medical Center
      • Tulsa, Oklahoma, Forenede Stater
        • 1160.24.01044 Tulsa Bone and Joint Associates
    • Oregon
      • Bend, Oregon, Forenede Stater
        • 1160.24.01002 The Orthopedic and Neurological Center of the Cascades
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater
        • 1160.24.01046 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater
        • 1160.24.01016
      • Conway, South Carolina, Forenede Stater
        • 1160.24.01073 Coastal Orthopedic Associates, PA
    • Texas
      • Austin, Texas, Forenede Stater
        • 1160.24.01032 Seton Medical Center
      • Dallas, Texas, Forenede Stater
        • 1160.24.01003 Texas Orthopedic Associates
      • Dallas, Texas, Forenede Stater
        • 1160.24.01090 VA Medical Center
      • Houston, Texas, Forenede Stater
        • 1160.24.01026 James Muntz, MD
      • Houston, Texas, Forenede Stater
        • 1160.24.01033 Bone and Joint Clinic of Houston
      • Houston, Texas, Forenede Stater
        • 1160.24.01076 Discovery Alliance
      • Lubbock, Texas, Forenede Stater
        • 1160.24.01018 Gill Research Center
      • Plano, Texas, Forenede Stater
        • 1160.24.01069 Correspondence and Pateint vists
      • San Antonio, Texas, Forenede Stater
        • 1160.24.01015 Unlimited Research, LP
    • Virginia
      • Alexandria, Virginia, Forenede Stater
        • 1160.24.01012 Anderson Orthopedic Clinic
    • Washington
      • Seattle, Washington, Forenede Stater
        • 1160.24.01052 Swedish Medical Center
      • Spokane, Washington, Forenede Stater
        • 1160.24.01057 Orthopedic Specialty Clinic of Spokane, PLLC
      • Tacoma, Washington, Forenede Stater
        • 1160.24.01082 MultiCare Health System
  • Mexico
      • Guadalajara, Jalisco, Mexico
        • 1160.24.05009 Traumatologia, Planta Baja
      • México, Mexico
        • 1160.24.05004

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dabigatran Dose 1
low dose regimen taken once daily
Medicin: Dabigatran Dose 1 - day 2 to completion
low dose regimen taken once daily
Medicin: Dabigatran Dose 1 - day 1
low dose regimen taken once daily
Eksperimentel: Dabigatran Dose 2
high dose regimen taken once daily
Medicin: Dabigatran Dose 2 - day 2 to completion
high dose regimen taken once daily
Medicin: Dabigatran Dose 2 - day 1
high dose regimen taken once daily
Aktiv komparator: Enoxaparin
30 mg subcutaneously twice daily
Medicin: Enoxaparin
30 mg subcutaneously twice daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2004

Primær færdiggørelse (Faktiske)

1. juni 2006

Studieafslutning

7. december 2022

Datoer for studieregistrering

Først indsendt

8. september 2005

Først indsendt, der opfyldte QC-kriterier

8. september 2005

Først opslået (Skøn)

12. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1160.24

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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