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A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00246025
Recruitment Status : Completed
First Posted : October 30, 2005
Results First Posted : December 17, 2010
Last Update Posted : June 9, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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Brief Summary:
The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Venous Thrombosis Drug: Dabigatran etexilate Drug: Dabigatran Etexilate Drug: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 512 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomised, Parallel-group, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery
Study Start Date : October 2005
Actual Primary Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dabigatran etexilate 110 mg
Dabigatran etexilate 110 mg capsule, once a day, oral administration
 Drug: Dabigatran etexilate
Dabigatran etexilate 110 mg capsule, once a day, oral administration
Experimental: Dabigatran etexilate 150 mg
Dabigatran etexilate 150 mg capsule, once a day, oral administration
 Drug: Dabigatran etexilate
Dabigatran etexilate 150 mg capsule, once a day, oral administration
Experimental: Dabigatran etexilate 220 mg
Dabigatran etexilate 110 mg capsule, 2capsules, once a day, oral administration
 Drug: Dabigatran Etexilate
Dabigatran etexilate 220 mg capsule, once a day, oral administration
Placebo Comparator: Placebo
matching placebo capsule, once a day, oral administration
 Drug: placebo
matching placebo capsule, once a day, oral administration


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period. [ Time Frame: 2 weeks study medication ]
    number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality


Secondary Outcome Measures :
  1. Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality [ Time Frame: 2 weeks ]
    Number of participants with the composite of major VTE (defined as proximal DVT and PE) and VTE related mortality

  2. Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period [ Time Frame: 2 weeks ]
    Number of participants who have Proximal DVT during treatment period

  3. Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis) [ Time Frame: 2 weeks ]
    Number of Participants expressing DVT with symptoms

  4. Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period [ Time Frame: 2 weeks ]
    Number of participants who have Total DVT during treatment period

  5. Number of Participants With Pulmonary Embolism During Treatment Period [ Time Frame: 2 weeks ]
    Pulmonary embolism confirmed by pulmonary scintigraphy, pulmonary angiography or contrast CT.

  6. Number of Participants Who Died During Treatment Period [ Time Frame: 2 weeks ]
    All cause death, as adjudicated by the VTE events committee.

  7. Number of Participants With Bleeding Events During Treatment Period [ Time Frame: 2 weeks ]

    Major bleeding events were defined as

    • fatal
    • clinically overt associated with loss of haemoglobin >=2g/dL in excess of what was expected
    • clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
    • symptomatic retroperitoneal, intracranial, intraocular or intraspinal
    • requiring treatment cessation
    • leading to re-operation

    Clinically-relevant was defined as

    • spontaneous skin hematoma >=25 cm²
    • wound hematoma >=100 cm²
    • spontaneous nose bleed >5 min
    • macroscopic hematuria spontaneous or >24 hours if associated with an intervention
    • spontaneous rectal bleeding (more than a spot on toilet paper)
    • gingival bleeding >5 min
    • any other bleeding event considered clinically relevant by the investigator

    Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.


  8. Blood Transfusion [ Time Frame: Day 0 ]
    Blood transfusion for treated and operated patients on Day of surgery.

  9. Volume of Blood Loss [ Time Frame: Day 0 ]
    Volume of blood loss for treated and operated patients during surgery.

  10. Laboratory Analyses [ Time Frame: First administration to end of study ]
    Frequency of patients with possible clinically significant abnormalities.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria Inclusion criteria

  1. Patients scheduled to undergo a primary, unilateral elective total knee replacement
  2. Male or Female 20 years of age or order
  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. Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV (arteriovenous) malformation or aneurysm or recent bleeding history
  6. Condition requiring anti-coagulant therapy
  7. Elevated AST(Aspartate Aminotransferase) , ALT(Alanine Aminotransferase), or any history of clinically relevant liver disease
  8. Patients with a history of clinically significant renal diseases or with elevated creatinine values
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246025


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00246025    
Other Study ID Numbers: 1160.50
First Posted: October 30, 2005    Key Record Dates
Results First Posted: December 17, 2010
Last Update Posted: June 9, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
 Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants