Back to resultsBIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery
Primary Purpose
Venous Thromboembolism
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BIBR 1048
Sponsored by
About this trial
This is an interventional treatment trial for Venous Thromboembolism
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled to undergo a primary elective total hip replacement
- Male of female being 18 years or older
- Patients weighing at least 40 kg
- Written informed consent for study participation
Exclusion Criteria:
- Bleeding diathesis, constitutional or acquired coagulation disorders
- Major surgery or trauma (e.g. hip fracture) within the last three months. Patients with previous hip fractures associated with plate revisions at any time will be excluded
- Cardiovascular disease including uncontrolled hypertension at time of enrolment or history of myocardial infarction within the last 6 months
- Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks
- Known history of deep venous thrombosis (DVT)
- Gastrointestinal or pulmonary bleeding within the last year
- Known liver disease Aspartate transaminase (AST) or Alanine transaminase (ALT) > 3 x ULN)
- Known renal disease (serum creatinine > 1.5 x ULN)
- Use of long- term anticoagulants, antiplatelet drugs, or fibrinolytics within 7 days prior to hip replacement operation (also contraindicated during the period of prophylaxis)
- Women of childbearing potential
- Known allergy to radiopaque contrast media
- Known thrombocytopenia (prior platelet count below 100,000 cells/microliter)
- Active malignant disease
- Current H2 blocker or proton pump inhibitor treatment
- Current cytostatic treatment
- Treatment with an investigational drug in the past month
- Leg amputee
- Known alcohol or drug abuse
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BIBR 1048
Arm Description
Ascending doses (in mg) given twice daily
Outcomes
Primary Outcome Measures
Rate of venous thrombolic events
Changes from baseline in activated partial thromboplastin time (aPTT)
Changes from baseline in ecarin clotting time (ECT)
Changes from baseline in thrombin time (TT)
Rate of major bleeding events during treatment phase
Cpre,ss (predose plasma concentrations at steady state)
Cmax,ss (maximum plasma concentration at steady state (day 4))
Tmax,ss (time to reach Cmax,ss)
CLtot/f (total clearance of drug from plasma after oral administration)
AUCss (area under the plasma concentration curve of one dosing interval at steady state)
PTF (percent peak trough fluctuation for the last dosing interval)
Cmax,ss (maximum plasma concentration at steady state (day 4))
Secondary Outcome Measures
Venous thromboembolism diagnosed during the follow-up period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02170701
Brief Title
BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery
Official Title
Multicenter, Open-label, Ascending Dose Study of BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery. Bistro I
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
June 2001 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
To determine the therapeutic window of BIBR 1048 in order to select doses for further studies in the development plan.
Twice daily regimen will be tested for most dose levels and once daily administration will also be evaluated when appropriate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
289 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIBR 1048
Arm Type
Experimental
Arm Description
Ascending doses (in mg) given twice daily
Intervention Type
Drug
Intervention Name(s)
BIBR 1048
Intervention Description
Ascending doses (in mg) given twice daily
Primary Outcome Measure Information:
Title
Rate of venous thrombolic events
Time Frame
Up to day 10 after hip surgery
Title
Changes from baseline in activated partial thromboplastin time (aPTT)
Time Frame
From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10)
Title
Changes from baseline in ecarin clotting time (ECT)
Time Frame
From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10)
Title
Changes from baseline in thrombin time (TT)
Time Frame
From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10)
Title
Rate of major bleeding events during treatment phase
Time Frame
Start of treatment (day 0) until end of treatment (up to day 10)
Title
Cpre,ss (predose plasma concentrations at steady state)
Time Frame
baseline and predose from day 1 to last treatment day
Title
Cmax,ss (maximum plasma concentration at steady state (day 4))
Time Frame
Day 4
Title
Tmax,ss (time to reach Cmax,ss)
Time Frame
baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment
Title
CLtot/f (total clearance of drug from plasma after oral administration)
Time Frame
baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment
Title
AUCss (area under the plasma concentration curve of one dosing interval at steady state)
Time Frame
baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment
Title
PTF (percent peak trough fluctuation for the last dosing interval)
Time Frame
baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment
Title
Cmax,ss (maximum plasma concentration at steady state (day 4))
Time Frame
Day 4 before and 0.5, 1, 2, 4 , 8, 12 , 14 h after treatment
Secondary Outcome Measure Information:
Title
Venous thromboembolism diagnosed during the follow-up period
Time Frame
Up to 6 weeks after surgery (day 42)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled to undergo a primary elective total hip replacement
Male of female being 18 years or older
Patients weighing at least 40 kg
Written informed consent for study participation
Exclusion Criteria:
Bleeding diathesis, constitutional or acquired coagulation disorders
Major surgery or trauma (e.g. hip fracture) within the last three months. Patients with previous hip fractures associated with plate revisions at any time will be excluded
Cardiovascular disease including uncontrolled hypertension at time of enrolment or history of myocardial infarction within the last 6 months
Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks
Known history of deep venous thrombosis (DVT)
Gastrointestinal or pulmonary bleeding within the last year
Known liver disease Aspartate transaminase (AST) or Alanine transaminase (ALT) > 3 x ULN)
Known renal disease (serum creatinine > 1.5 x ULN)
Use of long- term anticoagulants, antiplatelet drugs, or fibrinolytics within 7 days prior to hip replacement operation (also contraindicated during the period of prophylaxis)
Women of childbearing potential
Known allergy to radiopaque contrast media
Known thrombocytopenia (prior platelet count below 100,000 cells/microliter)
Active malignant disease
Current H2 blocker or proton pump inhibitor treatment
Current cytostatic treatment
Treatment with an investigational drug in the past month
Leg amputee
Known alcohol or drug abuse
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.11_U02-1716.pdf
Description
Related Info
Learn more about this trial
BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery
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