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
- NCT00152971
- PHASE3
- INTERVENTIONAL
Last updated: 2014-05-05
Purpose of Trial
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
This study is for people with
Arthroplasty, Replacement, Knee
Thromboembolism
Interventions being studied
Dabigatran Dose 1 - day 2 to completion
Dabigatran Dose 1 - day 1
Dabigatran Dose 2 - day 2 to completion
Dabigatran Dose 2 - day 1
Enoxaparin
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.
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
59 Locations
Birmingham
1160.24.01074 Capstone Clinical Trials, Inc.
Alabama, United States
Northport
1160.24.01079 West AL Research, Inc
Alabama, United States
Tucson
1160.24.01047 Tucson Orhtopaedic Institute
Arizona, United States
Little Rock
1160.24.01025 Martin, Bowen, Hefley Knee and Sports
Arkansas, United States
Little Rock
1160.24.01053 OrthoArkansas, PA
Arkansas, United States
Little Rock
1160.24.01085 Martin, Bowen, Hefley Knee and Sports
Arkansas, United States
Encinitas
1160.24.01041 Core Orthopedic Medical Center
California, United States
Glendale
1160.24.01034 Glendale Adventist Medical Center
California, United States
La Jolla
1160.24.01005 Scripps Clinical Ctr for Orthopedic Rsrch & Educ
California, United States
Long Beach
1160.24.01077 Long Beach VA Healthcare system
California, United States
Orange
1160.24.01064 Orthopedic Specialty Institute
California, United States
Aurora
1160.24.01031 Colorodo Orthopedic Consultants, PC
Colorado, United States
Denver
1160.24.01027 Advanced Orthopedic and Sports Medicine Specialists, PC
Colorado, United States
Engelwood
1160.24.01023 Orthopedic Physicians of Colorado, PC
Colorado, United States
Bay Pines
1160.24.01020 Bay Pines VA Medical Center
Florida, United States
Brandon
1160.24.01024 Pulmonary Associates of Brandon Clinical Research
Florida, United States
Clearwater
1160.24.01030 Alliance Research, Inc.
Florida, United States
Deland
1160.24.01039 Florida Orthopedic Associates
Florida, United States
Hollywood
1160.24.01036 Orthopaedic Associates of South Broward, PA
Florida, United States
Melbourne
1160.24.01010 MIMA Century Research Associates
Florida, United States
Miami
1160.24.01062 Miami Institute for Joint Reconstruction
Florida, United States
Orlando
1160.24.01040 Southern Clinical Research Consultants
Florida, United States
Pensacola
1160.24.01067 Baptist Clinical Research
Florida, United States
Pinellas Park
1160.24.01001 Boehringer Ingelheim Investigational Site
Florida, United States
Pinellas Park
1160.24.01017 Boehringer Ingelheim Investigational Site
Florida, United States
Pinellas Park
1160.24.01019 Boehringer Ingelheim Investigational Site
Florida, United States
Port Orange
1160.24.01029 Coastal Medical Research
Florida, United States
Tampa
1160.24.01038 James A. Haley VA Hospital
Florida, United States
Atlanta
1160.24.01063 Resurgens Orthopaedics
Georgia, United States
Atlanta
1160.24.01072 Resurgeons Orthopedics
Georgia, United States
Lawrencville
1160.24.01056 Southern Orthopaedic Specialists
Georgia, United States
Boise
1160.24.01028 Intermountain Research Center
Idaho, United States
Des Moines
1160.24.01022 Iowa Orthopedic Clinic
Iowa, United States
Lexington
1160.24.01008 Bluegrass Orthopedic/Musculoskeletal Research, LLC
Kentucky, United States
Baltimore
1160.24.01070 Sinai Hospital of Baltimore
Maryland, United States
Towson
1160.24.01007 Ortho Associates
Maryland, United States
Kansas City
1160.24.01059 Rockhill Orthopaedics
Missouri, United States
Missoula
1160.24.01042 Center for Joint Care
Montana, United States
Charlotte
1160.24.01014 Charlotte Orthopedic Specialists
North Carolina, United States
Cincinnati
1160.24.01035 Wellington Orthopedics and Sports Medicine
Ohio, United States
Oklahoma City
1160.24.01006 VA Medical Center
Oklahoma, United States
Tulsa
1160.24.01044 Tulsa Bone and Joint Associates
Oklahoma, United States
Bend
1160.24.01002 The Orthopedic and Neurological Center of the Cascades
Oregon, United States
Philadelphia
1160.24.01046 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Charleston
1160.24.01016
South Carolina, United States
Conway
1160.24.01073 Coastal Orthopedic Associates, PA
South Carolina, United States
Austin
1160.24.01032 Seton Medical Center
Texas, United States
Dallas
1160.24.01003 Texas Orthopedic Associates
Texas, United States
Dallas
1160.24.01090 VA Medical Center
Texas, United States
Houston
1160.24.01026 James Muntz, MD
Texas, United States
Houston
1160.24.01033 Bone and Joint Clinic of Houston
Texas, United States
Houston
1160.24.01076 Discovery Alliance
Texas, United States
Lubbock
1160.24.01018 Gill Research Center
Texas, United States
Plano
1160.24.01069 Correspondence and Pateint vists
Texas, United States
San Antonio
1160.24.01015 Unlimited Research, LP
Texas, United States
Alexandria
1160.24.01012 Anderson Orthopedic Clinic
Virginia, United States
Seattle
1160.24.01052 Swedish Medical Center
Washington, United States
Spokane
1160.24.01057 Orthopedic Specialty Clinic of Spokane, PLLC
Washington, United States
Tacoma
1160.24.01082 MultiCare Health System
Washington, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov