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

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2016-002681-31-ES
• Date of registration: 23/05/2017
• Prospective Registration: Yes
• Primary sponsor: Bayer AG
• Public title: A study to investigate BAY 1213790 of different doses to prevent blood clot in patients having elective total knee replacement surgery
• Scientific title: 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
• Date of first enrolment: 13/07/2017
• Target sample size: 700
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002681-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: open-label for the assignment to the study drugs, observer blinded to the dose of BAY1213790 If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer AG

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer AG

Key inclusion & exclusion criteria

Inclusion criteria:
• Patients aged >= 8 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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion criteria:
• High risk for clinically significant bleeding or any of the following conditions:
o Anemia (Hb <10 g/dL in women, < 11 g/dL in men) at Screening
o Platelet count at Screening < 150 x 109/L or history of heparin-induced thrombocytopenia
o aPTT or PT (INR or Quick) > 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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Product Name: BAY 1213790
Product Code: BAY 1213790
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: N/A
Current Sponsor code: BAY 1213790
Other descriptive name: BAY 1213790
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Trade Name: Clexane
Product Name: enoxaparin
Product Code: enoxaparin 40 mg/0.4 ml, sol. for inj.
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ENOXAPARIN SODIUM
CAS Number: 9041-08-1
Current Sponsor code: Enoxaparin
Other descriptive name: Enoxaparin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Trade Name: Eliquis
Product Name: apixaban
Product Code: apixaban 2.5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: APIXABAN
CAS Number: 503612-47-3
Current Sponsor code: Apixaban
Other descriptive name: Apixaban
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-

Primary Outcome(s)

Primary end point(s): • Incidence of asymptomatic DVT, detected by mandatory bilateral venography, and objectively confirmed symptomatic DVT or non-fatal PE (symptomatic VTE), fatal PE and unexplained death for which PE cannot be excluded

• Incidence of major and clinically relevant non-major bleeding

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

Timepoint(s) of evaluation of this end point: Visit 7, Day 12+3

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Visit 10, Day 150±7

Secondary end point(s): • Incidence of symptomatic DVT or non-fatal PE (symptomatic VTE), fatal PE and unexplained death for which PE cannot be excluded up to Visit 10 (Day 150±7) or objectively confirmed asymptomatic DVT up to
Visit 7 (Day 12+3)

• Incidence of major and clinically relevant non-major bleeding

Secondary ID(s)

BAY1213790/17664

Source(s) of Monetary Support

Bayer AG

Ethics review

Status: Approved
Approval date:
Contact: