A Study to Investigate Different Doses of BAY1213790 to Prevent Blood Clots in Patients Undergoing Elective Total Knee Replacement Surgery

ID: NCT03276143
Status: Recruiting
Phase: Phase 2
Start Date: September 21, 2017
First Submitted: September 07, 2017
Last Updated: February 12, 2018
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: Bulgaria, Canada, Czechia, Germany, Greece, Israel, Latvia, Lithuania, Poland, Portugal, Russian Federation, South Africa, Spain, Ukraine
Conditions: Knee Arthroplasty, Total
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Study Description

Brief Summary

This study is to compare the study drug BAY1213790 to existing therapies, ie Enoxaparin or Apixaban for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). The study is open-label, but observer-blind for the different doses of BAY1213790 administered. This means that it is known which treatment is given, but it is not known which dose of BAY1213790 is administered.

Detailed Description

Condition or disease Intervention/treatment Phase

Knee Arthroplasty, Total

Drug: BAY1213790
Other Names
Drug: Enoxaparin
Other Names
Drug: Apixaban
Other Names
Phase 2

Tracking Information

First Submitted DateSeptember 07, 2017
Last Update Posted DateFebruary 12, 2018
Actual Start DateSeptember 21, 2017
Anticipated Completion DateSeptember 14, 2019
Actual Primary Completion DateApril 27, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded [Time Frame: up to Visit 7 (Day 12+3)]

    DVT: deep vein thrombosis PE: pulmonary embolism All suspected events will be reviewed and classified by the Central Independent Adjudication Committee

  • Incidence of composite endpoint of major and clinically relevant non-major bleeding [Time Frame: up to Visit 7 (Day 12+3)]

    All suspected events will be reviewed and classified by the Central Independent Adjudication Committee

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Incidence of composite endpoint of symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Day 150 or objectively confirmed asymptomatic DVT up to day 12 [Time Frame: up to Visit 10 (Day 150±7)]

    All suspected events will be reviewed and classified by the Central Independent Adjudication Committee

  • Incidence of composite endpoint of major and clinically relevant non-major bleeding [Time Frame: up to Visit 10 (Day 150±7)]

    All suspected events will be reviewed and classified by the Central Independent Adjudication Committee

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Study to Investigate Different Doses of BAY1213790 to Prevent Blood Clots in Patients Undergoing Elective Total Knee Replacement Surgery
Official TitleA Randomized, Active-comparator-controlled, Multicenter Study to Assess the Safety and Efficacy of Different Doses of BAY1213790 for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Primary Total Knee Arthroplasty, Open-label to Treatment and Observer-blinded to BAY1213790 Doses
Brief Summary

This study is to compare the study drug BAY1213790 to existing therapies, ie Enoxaparin or Apixaban for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). The study is open-label, but observer-blind for the different doses of BAY1213790 administered. This means that it is known which treatment is given, but it is not known which dose of BAY1213790 is administered.

Detailed Description

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
700
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Prevention
Conditions
Knee Arthroplasty, Total
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: BAY1213790

single dose intravenous infusion

Other Names
Drug: Enoxaparin

daily subcutaneous injection

Other Names
Drug: Apixaban

twice daily oral administration

Other Names
Study Groups/Cohorts
BAY1213790 pre and post surgery
Post-surgery administration part (A): Single infusion in the morning following the day of Total Knee Arthroplasty (TKA) Pre-surgery administration part (B): Single infusion in the second half of the day before Total Knee Arthroplasty (TKA)

Enoxaparin for at least 10 days
Started either in the evening before TKA or 6-8 hours after TKA (at investigator's discretion), followed by once daily subcutaneous injections for at least 10 days and until venography is performed

Apixaban for at least 10 days
For at least 10 days post-surgery and until venography is performed, starting within 12 to 24 hours after TKA surgery

Study Arms
Active Comparator Apixaban for at least 10 days
For at least 10 days post-surgery and until venography is performed, starting within 12 to 24 hours after TKA surgery
Drug : Apixaban
twice daily oral administration

Experimental BAY1213790 pre and post surgery
Post-surgery administration part (A): Single infusion in the morning following the day of Total Knee Arthroplasty (TKA) Pre-surgery administration part (B): Single infusion in the second half of the day before Total Knee Arthroplasty (TKA)
Drug : BAY1213790
single dose intravenous infusion

Active Comparator Enoxaparin for at least 10 days
Started either in the evening before TKA or 6-8 hours after TKA (at investigator's discretion), followed by once daily subcutaneous injections for at least 10 days and until venography is performed
Drug : Enoxaparin
daily subcutaneous injection

Arm Intervention/Treatment
Active Comparator Apixaban for at least 10 days
For at least 10 days post-surgery and until venography is performed, starting within 12 to 24 hours after TKA surgery
Drug : Apixaban
Experimental BAY1213790 pre and post surgery
Post-surgery administration part (A): Single infusion in the morning following the day of Total Knee Arthroplasty (TKA) Pre-surgery administration part (B): Single infusion in the second half of the day before Total Knee Arthroplasty (TKA)
Drug : BAY1213790
Active Comparator Enoxaparin for at least 10 days
Started either in the evening before TKA or 6-8 hours after TKA (at investigator's discretion), followed by once daily subcutaneous injections for at least 10 days and until venography is performed
Drug : Enoxaparin

Recruitment Information

Recruitment Status:Recruiting
Enrollment700
Completion DateSeptember 14, 2019
Eligibility Criteria: Inclusion Criteria:
- Patients aged ≥18 years undergoing elective primary, unilateral TKA For women,
- Women of non-childbearing potential

Exclusion Criteria:
- High risk for clinically significant bleeding
- Prior deep vein thrombosis
- Creatinine clearance below 60 ml/min
- Active cancer except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been curatively treated
- Contraindication listed in the local label of the comparator treatments
- Requirement for full dose anticoagulation or dual antiplatelet therapy (low dose of acetylsalicylic acid is allowed)
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Bulgaria
Canada
Czechia
Germany
Greece
Israel
Latvia
Lithuania
Poland
Portugal
Russian Federation
South Africa
Spain
Ukraine
Hungary

Administrative Information

NCT Number:NCT03276143
Other Study ID Numbers
17664
2016-002681-31
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer