A study to investigate BAY 1213790 of different doses to prevent blood clot in patients having elective total knee replacement surgery

A randomized, active-comparator-controlled, multicenter study to assess the safety and efficacy of different doses of BAY 1213790 for the prevention of venous thromboembolism in patients undergoing elective primary total knee arthroplasty, open-label to treatment and observer-blinded to BAY 1213790 doses - FOXTROT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002681-31-BG

Enrollment

900

Registered

2017-07-06

Start date

2017-10-11

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of venous thromboembolism MedDRA version: 20.0 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865

Interventions

Product Name: BAY 1213790 Product Code: BAY 1213790 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: N/A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients aged =18 years undergoing elective primary, unilateral TKA • Women of non-childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 450

Exclusion criteria

Exclusion criteria: • High risk for clinically significant bleeding or any of the following conditions: o Anemia (Hb ULN at Screening o Hepatic disease associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) > 3x upper level of normal (ULN) or total bilirubin (TB) > 2x ULN with direct bilirubin > 20% of the total at Screening o Brain, spinal, or ophthalmologic surgery (except cataract surgery) within 3 months prior to randomization o Known bleeding disorders • Prior deep vein thrombosis • Creatinine clearance below 60 ml/min, calculated by MDRD formula at Screening • 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)

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): • incidence of composite endpoint of symptomatic DVT or non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Visit 10 (Day 150±7), objectively confirmed asymptomatic DVT up to Visit 7 (Day 12+3) • incidence of composite of major and clinically relevant non-major bleeding up to Visit 10 (Day 150±7) ;Timepoint(s) of evaluation of this end point: Visit 10, Day 150±7	—

Measure

Time frame

Secondary end point(s): • incidence of composite endpoint of symptomatic DVT or non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Visit 10 (Day 150±7), objectively confirmed asymptomatic DVT up to Visit 7 (Day 12+3) • incidence of composite of major and clinically relevant non-major bleeding up to Visit 10 (Day 150±7) ;Timepoint(s) of evaluation of this end point: Visit 10, Day 150±7

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Primary

Measure	Time frame
Main Objective: To assess the safety and efficacy of different doses of BAY 1213790 in comparison with those of enoxaparin in patients undergoing elective, primary, unilateral total knee arthroplasty (TKA) ; Secondary Objective: To compare the safety and efficacy of BAY 1213790 with those of apixaban ; Primary end point(s): • incidence of composite endpoint consisting of asymptomatic DVT; detected by mandatory bilateral venography; objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Visit 7 (Day 12+3) • incidence of composite of major and clinically relevant non-major bleeding up to Visit 7 (Day 12+3) ;Timepoint(s) of evaluation of this end point: Visit 7, Day 12+3	—

Measure

Time frame

Main Objective: To assess the safety and efficacy of different doses of BAY 1213790 in comparison with those of enoxaparin in patients undergoing elective, primary, unilateral total knee arthroplasty (TKA) ; Secondary Objective: To compare the safety and efficacy of BAY 1213790 with those of apixaban ; Primary end point(s): • incidence of composite endpoint consisting of asymptomatic DVT; detected by mandatory bilateral venography; objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Visit 7 (Day 12+3) • incidence of composite of major and clinically relevant non-major bleeding up to Visit 7 (Day 12+3) ;Timepoint(s) of evaluation of this end point: Visit 7, Day 12+3

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Countries

Bulgaria, Canada, Czech Republic, Germany, Greece, Israel, Latvia, Lithuania, Poland, Portugal, Russian Federation, South Africa, Spain, Ukraine

Contacts

Public ContactBayer Clinical Trials Contact

Bayer AG

clinical-trials-contact@bayer.com004930300139003

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026