Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement
Condition: Arthroplasty, Replacement, Knee; Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: 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
Intervention description: low dose regimen taken once daily; low dose regimen taken once daily; high dose regimen taken once daily; high dose regimen taken once daily; 30 mg subcutaneously twice daily
Intervention MeSH terms: Enoxaparin; Dabigatran
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 2615.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 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
    

Eligibility criteria:

        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.