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

Primary Purpose

Arthroplasty, Replacement, Knee, Venous Thrombosis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Dabigatran etexilate
Dabigatran etexilate
Dabigatran Etexilate
placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthroplasty, Replacement, Knee

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1160.50.001 Boehringer Ingelheim Investigational Site
  • 1160.50.018 Boehringer Ingelheim Investigational Site
  • 1160.50.008 Boehringer Ingelheim Investigational Site
  • 1160.50.006 Boehringer Ingelheim Investigational Site
  • 1160.50.026 Boehringer Ingelheim Investigational Site
  • 1160.50.011 Boehringer Ingelheim Investigational Site
  • 1160.50.024 Boehringer Ingelheim Investigational Site
  • 1160.50.045 Boehringer Ingelheim Investigational Site
  • 1160.50.022 Boehringer Ingelheim Investigational Site
  • 1160.50.027 Boehringer Ingelheim Investigational Site
  • 1160.50.032 Boehringer Ingelheim Investigational Site
  • 1160.50.041 Boehringer Ingelheim Investigational Site
  • 1160.50.039 Boehringer Ingelheim Investigational Site
  • 1160.50.037 Boehringer Ingelheim Investigational Site
  • 1160.50.038 Boehringer Ingelheim Investigational Site
  • 1160.50.013 Boehringer Ingelheim Investigational Site
  • 1160.50.036 Boehringer Ingelheim Investigational Site
  • 1160.50.042 Boehringer Ingelheim Investigational Site
  • 1160.50.028 Boehringer Ingelheim Investigational Site
  • 1160.50.005 Boehringer Ingelheim Investigational Site
  • 1160.50.030 Boehringer Ingelheim Investigational Site
  • 1160.50.021 Boehringer Ingelheim Investigational Site
  • 1160.50.014 Boehringer Ingelheim Investigational Site
  • 1160.50.015 Boehringer Ingelheim Investigational Site
  • 1160.50.016 Boehringer Ingelheim Investigational Site
  • 1160.50.033 Boehringer Ingelheim Investigational Site
  • 1160.50.031 Boehringer Ingelheim Investigational Site
  • 1160.50.009 Boehringer Ingelheim Investigational Site
  • 1160.50.002 Boehringer Ingelheim Investigational Site
  • 1160.50.004 Boehringer Ingelheim Investigational Site
  • 1160.50.020 Boehringer Ingelheim Investigational Site
  • 1160.50.025 Boehringer Ingelheim Investigational Site
  • 1160.50.034 Boehringer Ingelheim Investigational Site
  • 1160.50.029 Boehringer Ingelheim Investigational Site
  • 1160.50.043 Boehringer Ingelheim Investigational Site
  • 1160.50.044 Boehringer Ingelheim Investigational Site
  • 1160.50.023 Boehringer Ingelheim Investigational Site
  • 1160.50.040 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Dabigatran etexilate 110 mg

Dabigatran etexilate 150 mg

Dabigatran etexilate 220 mg

Placebo

Arm Description

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

Dabigatran etexilate 150 mg capsule, once a day, oral administration

Dabigatran etexilate 110 mg capsule, 2capsules, once a day, oral administration

matching placebo capsule, once a day, oral administration

Outcomes

Primary Outcome Measures

Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.
number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality

Secondary Outcome Measures

Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality
Number of participants with the composite of major VTE (defined as proximal DVT and PE) and VTE related mortality
Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period
Number of participants who have Proximal DVT during treatment period
Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)
Number of Participants expressing DVT with symptoms
Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period
Number of participants who have Total DVT during treatment period
Number of Participants With Pulmonary Embolism During Treatment Period
Pulmonary embolism confirmed by pulmonary scintigraphy, pulmonary angiography or contrast CT.
Number of Participants Who Died During Treatment Period
All cause death, as adjudicated by the VTE events committee.
Number of Participants With Bleeding Events During Treatment Period
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.
Blood Transfusion
Blood transfusion for treated and operated patients on Day of surgery.
Volume of Blood Loss
Volume of blood loss for treated and operated patients during surgery.
Laboratory Analyses
Frequency of patients with possible clinically significant abnormalities.

Full Information

First Posted
October 28, 2005
Last Updated
June 3, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00246025
Brief Title
A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.
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 Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Knee, Venous Thrombosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
512 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dabigatran etexilate 110 mg
Arm Type
Experimental
Arm Description
Dabigatran etexilate 110 mg capsule, once a day, oral administration
Arm Title
Dabigatran etexilate 150 mg
Arm Type
Experimental
Arm Description
Dabigatran etexilate 150 mg capsule, once a day, oral administration
Arm Title
Dabigatran etexilate 220 mg
Arm Type
Experimental
Arm Description
Dabigatran etexilate 110 mg capsule, 2capsules, once a day, oral administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo capsule, once a day, oral administration
Intervention Type
Drug
Intervention Name(s)
Dabigatran etexilate
Intervention Description
Dabigatran etexilate 110 mg capsule, once a day, oral administration
Intervention Type
Drug
Intervention Name(s)
Dabigatran etexilate
Intervention Description
Dabigatran etexilate 150 mg capsule, once a day, oral administration
Intervention Type
Drug
Intervention Name(s)
Dabigatran Etexilate
Intervention Description
Dabigatran etexilate 220 mg capsule, once a day, oral administration
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
matching placebo capsule, once a day, oral administration
Primary Outcome Measure Information:
Title
Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.
Description
number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality
Time Frame
2 weeks study medication
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality
Description
Number of participants with the composite of major VTE (defined as proximal DVT and PE) and VTE related mortality
Time Frame
2 weeks
Title
Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period
Description
Number of participants who have Proximal DVT during treatment period
Time Frame
2 weeks
Title
Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)
Description
Number of Participants expressing DVT with symptoms
Time Frame
2 weeks
Title
Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period
Description
Number of participants who have Total DVT during treatment period
Time Frame
2 weeks
Title
Number of Participants With Pulmonary Embolism During Treatment Period
Description
Pulmonary embolism confirmed by pulmonary scintigraphy, pulmonary angiography or contrast CT.
Time Frame
2 weeks
Title
Number of Participants Who Died During Treatment Period
Description
All cause death, as adjudicated by the VTE events committee.
Time Frame
2 weeks
Title
Number of Participants With Bleeding Events During Treatment Period
Description
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.
Time Frame
2 weeks
Title
Blood Transfusion
Description
Blood transfusion for treated and operated patients on Day of surgery.
Time Frame
Day 0
Title
Volume of Blood Loss
Description
Volume of blood loss for treated and operated patients during surgery.
Time Frame
Day 0
Title
Laboratory Analyses
Description
Frequency of patients with possible clinically significant abnormalities.
Time Frame
First administration to end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.50.001 Boehringer Ingelheim Investigational Site
City
Eniwa, Hokkaido
Country
Japan
Facility Name
1160.50.018 Boehringer Ingelheim Investigational Site
City
Fukuoka, Fukuoka
Country
Japan
Facility Name
1160.50.008 Boehringer Ingelheim Investigational Site
City
Hachioji, Tokyo
Country
Japan
Facility Name
1160.50.006 Boehringer Ingelheim Investigational Site
City
Hirosaki, Aomori
Country
Japan
Facility Name
1160.50.026 Boehringer Ingelheim Investigational Site
City
Hiroshima, Hiroshima
Country
Japan
Facility Name
1160.50.011 Boehringer Ingelheim Investigational Site
City
Iida, Nagano
Country
Japan
Facility Name
1160.50.024 Boehringer Ingelheim Investigational Site
City
Izumisano, Osaka
Country
Japan
Facility Name
1160.50.045 Boehringer Ingelheim Investigational Site
City
Izunokuni,Shizuoka
Country
Japan
Facility Name
1160.50.022 Boehringer Ingelheim Investigational Site
City
Kagoshima, Kagoshima
Country
Japan
Facility Name
1160.50.027 Boehringer Ingelheim Investigational Site
City
Kawasaki, Kanagawa
Country
Japan
Facility Name
1160.50.032 Boehringer Ingelheim Investigational Site
City
Kawasaki, Kanagawa
Country
Japan
Facility Name
1160.50.041 Boehringer Ingelheim Investigational Site
City
Kitakyusyu, Fukuoka
Country
Japan
Facility Name
1160.50.039 Boehringer Ingelheim Investigational Site
City
Koshigaya,Saitama
Country
Japan
Facility Name
1160.50.037 Boehringer Ingelheim Investigational Site
City
Kurume ,Fukuoka
Country
Japan
Facility Name
1160.50.038 Boehringer Ingelheim Investigational Site
City
Kurume ,Fukuoka
Country
Japan
Facility Name
1160.50.013 Boehringer Ingelheim Investigational Site
City
Kyoto, Kyoto
Country
Japan
Facility Name
1160.50.036 Boehringer Ingelheim Investigational Site
City
Matsue, Shimane
Country
Japan
Facility Name
1160.50.042 Boehringer Ingelheim Investigational Site
City
Miyazaki, Miyazaki
Country
Japan
Facility Name
1160.50.028 Boehringer Ingelheim Investigational Site
City
Musashimurayama, Tokyo
Country
Japan
Facility Name
1160.50.005 Boehringer Ingelheim Investigational Site
City
Obihiro, Hokkaido
Country
Japan
Facility Name
1160.50.030 Boehringer Ingelheim Investigational Site
City
Okayama, Okayama
Country
Japan
Facility Name
1160.50.021 Boehringer Ingelheim Investigational Site
City
Omura, Nagasaki
Country
Japan
Facility Name
1160.50.014 Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
Country
Japan
Facility Name
1160.50.015 Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
Country
Japan
Facility Name
1160.50.016 Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
Country
Japan
Facility Name
1160.50.033 Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
Country
Japan
Facility Name
1160.50.031 Boehringer Ingelheim Investigational Site
City
Saga, Saga
Country
Japan
Facility Name
1160.50.009 Boehringer Ingelheim Investigational Site
City
Sagamihara, Kanagawa
Country
Japan
Facility Name
1160.50.002 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1160.50.004 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1160.50.020 Boehringer Ingelheim Investigational Site
City
Sasebo, Nagasaki
Country
Japan
Facility Name
1160.50.025 Boehringer Ingelheim Investigational Site
City
Sasebo, Nagasaki
Country
Japan
Facility Name
1160.50.034 Boehringer Ingelheim Investigational Site
City
Sendai, Miyagi
Country
Japan
Facility Name
1160.50.029 Boehringer Ingelheim Investigational Site
City
Shinjuku-ku,Tokyo
Country
Japan
Facility Name
1160.50.043 Boehringer Ingelheim Investigational Site
City
Shizuoka, Shizuoka
Country
Japan
Facility Name
1160.50.044 Boehringer Ingelheim Investigational Site
City
Sumida-ku, Tokyo
Country
Japan
Facility Name
1160.50.023 Boehringer Ingelheim Investigational Site
City
Tomigusuku, Okinawa
Country
Japan
Facility Name
1160.50.040 Boehringer Ingelheim Investigational Site
City
Tsukuba , Ibaraki
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.50_U07-3436-01-DS.pdf
Description
Related Info

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

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