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Dabigatran Etexilate vs Enoxaparin in Prevention of VTE Post Total Knee Replacement
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00152971
  Purpose

To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by150 m g 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 t hromboembolism in patients with primary elective total knee replacement surgery


Condition Intervention Phase
Arthroplasty, Replacement, Knee
Thromboembolism
Drug: dabigatran
Phase III

MedlinePlus related topics: Knee Replacement
Drug Information available for: Dabigatran etexilate Dabigatran Enoxaparin Sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title: 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 (Cap

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • A composite endpoint consisting of total Venous Thromboembolic Events (VTE) and all cause mortality during the treatment period.

Secondary Outcome Measures:
  • Composite of major VTE (defined as proximal DVT and PE) and VTE related mortality Proximal DVT Total DVT Symptomatic DVT Pulmonary Embolism (PE) Death Composite of total VTE and all-cause mortality during the follow-up

Estimated Enrollment: 2610
Estimated Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  1. History of bleeding diathesis.
  2. Constitutional or acquired coagulation disorders that in the investigator's j udgment 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 infarc tion within the last 3 months.
  5. Spinal or epidural anesthesia, for which more than 3 attempts (sticks) at pla cement were made, or the placement was traumatic. Please note that patients, who are not excluded under this criterion, are to hav e the catheter pulled at the completion of surgery.
  6. Any history of hemorrhagic stroke or any of the following intracranial pathol ogies: bleeding, neoplasm, AV malformation or aneurysm.
  7. History of VTE or pre-existing condition requiring anticoagulant therapy.
  8. Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular o r 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. hepati tis B or C, cirrhosis, but not Gilbert's syndrome or hepatitis A with complete r ecovery).
  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) n eeds to be calculated only if serum creatinine is elevated or renal insufficienc y is suspected.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152971

  Show 88 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Pharmaceuticals
  More Information

Study ID Numbers: 1160.24
Study First Received: September 8, 2005
Last Updated: August 30, 2007
ClinicalTrials.gov Identifier: NCT00152971  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Embolism and Thrombosis
Embolism
Vascular Diseases
Thrombosis
Thromboembolism
Enoxaparin

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009