Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement
NCT ID: NCT00152971
Last Updated: 2014-05-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2615 participants
INTERVENTIONAL
2004-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Dabigatran Dose 1
low dose regimen taken once daily
Dabigatran Dose 1 - day 2 to completion
low dose regimen taken once daily
Dabigatran Dose 1 - day 1
low dose regimen taken once daily
Dabigatran Dose 2
high dose regimen taken once daily
Dabigatran Dose 2 - day 2 to completion
high dose regimen taken once daily
Dabigatran Dose 2 - day 1
high dose regimen taken once daily
Enoxaparin
30 mg subcutaneously twice daily
Enoxaparin
30 mg subcutaneously twice daily
Interventions
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Dabigatran Dose 1 - day 2 to completion
low dose regimen taken once daily
Dabigatran Dose 1 - day 1
low dose regimen taken once daily
Dabigatran Dose 2 - day 2 to completion
high dose regimen taken once daily
Dabigatran Dose 2 - day 1
high dose regimen taken once daily
Enoxaparin
30 mg subcutaneously twice daily
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Boehringer Ingelheim
Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1160.24.01074 Capstone Clinical Trials, Inc.
Birmingham, Alabama, United States
1160.24.01079 West AL Research, Inc
Northport, Alabama, United States
1160.24.01047 Tucson Orhtopaedic Institute
Tucson, Arizona, United States
1160.24.01025 Martin, Bowen, Hefley Knee and Sports
Little Rock, Arkansas, United States
1160.24.01053 OrthoArkansas, PA
Little Rock, Arkansas, United States
1160.24.01085 Martin, Bowen, Hefley Knee and Sports
Little Rock, Arkansas, United States
1160.24.01041 Core Orthopedic Medical Center
Encinitas, California, United States
1160.24.01034 Glendale Adventist Medical Center
Glendale, California, United States
1160.24.01005 Scripps Clinical Ctr for Orthopedic Rsrch & Educ
La Jolla, California, United States
1160.24.01077 Long Beach VA Healthcare system
Long Beach, California, United States
1160.24.01064 Orthopedic Specialty Institute
Orange, California, United States
1160.24.01031 Colorodo Orthopedic Consultants, PC
Aurora, Colorado, United States
1160.24.01027 Advanced Orthopedic and Sports Medicine Specialists, PC
Denver, Colorado, United States
1160.24.01023 Orthopedic Physicians of Colorado, PC
Engelwood, Colorado, United States
1160.24.01020 Bay Pines VA Medical Center
Bay Pines, Florida, United States
1160.24.01024 Pulmonary Associates of Brandon Clinical Research
Brandon, Florida, United States
1160.24.01030 Alliance Research, Inc.
Clearwater, Florida, United States
1160.24.01039 Florida Orthopedic Associates
DeLand, Florida, United States
1160.24.01036 Orthopaedic Associates of South Broward, PA
Hollywood, Florida, United States
1160.24.01010 MIMA Century Research Associates
Melbourne, Florida, United States
1160.24.01062 Miami Institute for Joint Reconstruction
Miami, Florida, United States
1160.24.01040 Southern Clinical Research Consultants
Orlando, Florida, United States
1160.24.01067 Baptist Clinical Research
Pensacola, Florida, United States
1160.24.01001 Boehringer Ingelheim Investigational Site
Pinellas Park, Florida, United States
1160.24.01017 Boehringer Ingelheim Investigational Site
Pinellas Park, Florida, United States
1160.24.01019 Boehringer Ingelheim Investigational Site
Pinellas Park, Florida, United States
1160.24.01029 Coastal Medical Research
Port Orange, Florida, United States
1160.24.01038 James A. Haley VA Hospital
Tampa, Florida, United States
1160.24.01063 Resurgens Orthopaedics
Atlanta, Georgia, United States
1160.24.01072 Resurgeons Orthopedics
Atlanta, Georgia, United States
1160.24.01056 Southern Orthopaedic Specialists
Lawrencville, Georgia, United States
1160.24.01028 Intermountain Research Center
Boise, Idaho, United States
1160.24.01022 Iowa Orthopedic Clinic
Des Moines, Iowa, United States
1160.24.01008 Bluegrass Orthopedic/Musculoskeletal Research, LLC
Lexington, Kentucky, United States
1160.24.01070 Sinai Hospital of Baltimore
Baltimore, Maryland, United States
1160.24.01007 Ortho Associates
Towson, Maryland, United States
1160.24.01059 Rockhill Orthopaedics
Kansas City, Missouri, United States
1160.24.01042 Center for Joint Care
Missoula, Montana, United States
1160.24.01014 Charlotte Orthopedic Specialists
Charlotte, North Carolina, United States
1160.24.01035 Wellington Orthopedics and Sports Medicine
Cincinnati, Ohio, United States
1160.24.01006 VA Medical Center
Oklahoma City, Oklahoma, United States
1160.24.01044 Tulsa Bone and Joint Associates
Tulsa, Oklahoma, United States
1160.24.01002 The Orthopedic and Neurological Center of the Cascades
Bend, Oregon, United States
1160.24.01046 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1160.24.01016
Charleston, South Carolina, United States
1160.24.01073 Coastal Orthopedic Associates, PA
Conway, South Carolina, United States
1160.24.01032 Seton Medical Center
Austin, Texas, United States
1160.24.01003 Texas Orthopedic Associates
Dallas, Texas, United States
1160.24.01090 VA Medical Center
Dallas, Texas, United States
1160.24.01026 James Muntz, MD
Houston, Texas, United States
1160.24.01033 Bone and Joint Clinic of Houston
Houston, Texas, United States
1160.24.01076 Discovery Alliance
Houston, Texas, United States
1160.24.01018 Gill Research Center
Lubbock, Texas, United States
1160.24.01069 Correspondence and Pateint vists
Plano, Texas, United States
1160.24.01015 Unlimited Research, LP
San Antonio, Texas, United States
1160.24.01012 Anderson Orthopedic Clinic
Alexandria, Virginia, United States
1160.24.01052 Swedish Medical Center
Seattle, Washington, United States
1160.24.01057 Orthopedic Specialty Clinic of Spokane, PLLC
Spokane, Washington, United States
1160.24.01082 MultiCare Health System
Tacoma, Washington, United States
1160.24.02031 University of Alberta Hospital
Edmonton, Alberta, Canada
1160.24.02036 2B2.37 Walter Mackenizie Centre
Edmonton, Alberta, Canada
1160.24.02024 Red Deer Regional Hospital
Red Deer, Alberta, Canada
1160.24.02032 Kelowna General Hospital
Kelowna, British Columbia, Canada
1160.24.02034 Hematology/Oncology Research
Vancouver, British Columbia, Canada
1160.24.02025 Grace General Hospital
Winnipeg, Manitoba, Canada
1160.24.02007 Orthopaedics 4NE
Fredericton, New Brunswick, Canada
1160.24.02027 Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada
1160.24.02021 Rouge Valley Health System
Ajax, Ontario, Canada
1160.24.02008 Orthopaedic Surgery
Barrie, Ontario, Canada
1160.24.02016 Orthopaedic Surgery
Brantford, Ontario, Canada
1160.24.02010 Joseph Brant Memorial Hospital
Burlington, Ontario, Canada
1160.24.02001 73 Delhi Street
Guelph, Ontario, Canada
1160.24.02014 565 Sanatorium Road
Hamilton, Ontario, Canada
1160.24.02004 Grand River Hospital
Kitchener, Ontario, Canada
1160.24.02028 NHS- Greater Niagara General Site
Niagara Falls, Ontario, Canada
1160.24.02022 Lakeridge Health Oshawa
Oshawa, Ontario, Canada
1160.24.02017 1053 Carling Avenue
Ottawa, Ontario, Canada
1160.24.02026 Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
1160.24.02015 York Central Hospital Research
Richmond Hill, Ontario, Canada
1160.24.02029 Niagara Health System St. Catharine's General Site
Saint Catherine's, Ontario, Canada
1160.24.02009 2863 Ellesmere Road
Scarborough Village, Ontario, Canada
1160.24.02003 46 General Hospital Drive
Stratford, Ontario, Canada
1160.24.02033 Thunder Bay Regional Hospital
Thunder Bay, 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
Toronto, Ontario, Canada
1160.24.02006 206-477 King Street
Welland, Ontario, Canada
1160.24.02035 Humber River Regional Hospital
Weston, Ontario, Canada
1160.24.02011 Windsor Regional Hospital
Windsor, Ontario, Canada
1160.24.02012 Hotel Dieu Grace Hospital
Windsor, Ontario, Canada
1160.24.02013 Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada
1160.24.05009 Traumatologia, Planta Baja
Guadalajara, Jalisco, , Mexico
1160.24.05004
México, , Mexico
1160.24.44001 Ravenscourt Park Hospital
London, , United Kingdom
Countries
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References
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Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.
Other Identifiers
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1160.24
Identifier Type: -
Identifier Source: org_study_id
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