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Completed

NCT Number: NCT00246025

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

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.

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Key information

Conditions

Arthroplasty, Replacement, Knee Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1160.50.001 Boehringer Ingelheim Investigational Site, Eniwa, Hokkaido, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

  • Patients scheduled to undergo a primary, unilateral elective total knee replacement
  • Male or Female 20 years of age or order
  • 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
  • Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV (arteriovenous) malformation or aneurysm or recent bleeding history
  • Condition requiring anti-coagulant therapy
  • Elevated AST(Aspartate Aminotransferase) , ALT(Alanine Aminotransferase), or any history of clinically relevant liver disease
  • Patients with a history of clinically significant renal diseases or with elevated creatinine values

Treatment and study plan

Dabigatran Etexilate

Drug

Dabigatran etexilate 110 mg capsule, once a day, oral administration

Placebo

Drug

matching placebo capsule, once a day, oral administration

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
First posted
Oct 31, 2005
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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