A study to investigate BAY 1213790 of different doses to prevent blood clot in patients having elective total knee replacement surgery
- Conditions
- Prevention of venous thromboembolismMedDRA version: 20.0Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2016-002681-31-DE
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 700
• 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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350
• 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) <br>;Secondary Objective: To compare the safety and efficacy of BAY 1213790 with those of apixaban <br>;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<br> <br>• Incidence of major and clinically relevant non-major bleeding <br><br>;Timepoint(s) of evaluation of this end point: Visit 7, Day 12+3
- Secondary Outcome Measures
Name Time Method 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)<br><br>• Incidence of major and clinically relevant non-major bleeding <br>;Timepoint(s) of evaluation of this end point: Visit 10, Day 150±7
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.