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

Phase 1

Active, not recruiting

• Conditions: 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]

• Registration Number: EUCTR2016-002681-31-LT
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-29
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 900

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

• 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