Status:
COMPLETED
Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Arthroplasty, Replacement, Knee
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 administere...
Eligibility Criteria
Inclusion
- Inclusion criteria INCLUSION CRITERIA
- Patients scheduled to undergo a primary, unilateral elective total knee repla cement.
- Male or female 18 years of age or older.
- Patients weighing at least 40 kg.
- Written informed consent prior to the start of study participation.
- Exclusion criteria EXCLUSION CRITERIA
- History of bleeding diathesis.
- Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding.
- Major surgery or trauma (e.g. hip fracture) within the last 3 months.
- 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.
- 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.
- Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm.
- History of VTE or pre-existing condition requiring anticoagulant therapy.
- Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months.
- Gastric or duodenal ulcer within the last 6 months.
- 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).
- Elevated AST or ALT \>2x upper limit of normal, based on central lab results or local lab results within 1 month before enrollment.
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2615 Patients enrolled
Trial Details
Trial ID
NCT00152971
Start Date
November 1 2004
Last Update
May 5 2014
Active Locations (94)
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1
1160.24.01074 Capstone Clinical Trials, Inc.
Birmingham, Alabama, United States
2
1160.24.01079 West AL Research, Inc
Northport, Alabama, United States
3
1160.24.01047 Tucson Orhtopaedic Institute
Tucson, Arizona, United States
4
1160.24.01025 Martin, Bowen, Hefley Knee and Sports
Little Rock, Arkansas, United States