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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran; Enoxaparin

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.