None listed
Conditions
Interventions
Group 1 Type of group
YM150 15 mg bid orally starting the administration 6 to 10 hours after the end of the surgery, that is, with the closure of the wound.
Group name:Group 5 Type of group
Enoxaparin (or placebo) will be administered subcutaneously once a day at a dose of 40 mg per day, starting administration 12 +/- 2 hours before the scheduled surgery.
Sponsors
Astellas Pharma Europe B.V,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Written informed consent [and the Authorization of the Health Insurance Responsibility and Transferability Act (HIPPA) only for centers in the United States of America] were obtained before making the selection. • Man or woman 18 years of age or older. • Elective hip replacement surgery is planned for the subject.
Exclusion criteria
Exclusion criteria: • Female subject of childbearing potential who refuses to use a medically acceptable form of contraception throughout the study. (Acceptable methods of contraception are: oral or injectable hormonal contraceptives, intrauterine devices, vaginal hormonal rings, and only in combination with a male condom a vaginal diaphragm or cervical caps. Male study subjects should be advised to use male condom in addition to having their partner use another acceptable method during the study and for three months after the last dose.) • Female subject who is pregnant or lactating, or has a positive pregnancy test within 72 hours prior to randomization. • Subject has active bleeding or any condition associated with increased risk of bleeding including known hemorrhagic disorder or thrombocytopenia (platelet count 163 mg/day) at any time during the period extending from one week before the start of study drug until the end of the treatment period of 35 days. • Subject has hypersensitivity or any contraindications to iodinated contrast medium or enoxaparin. • Subject has planned indwelling intrathecal or epidural catheter for more than 6 hours after the end of surgery. • Subject has a creatinine clearance of 2 times or total bilirubin > 1.5 times ULN at screening. • Subject has a lower extremity amputation (toe(s) amputation only is acceptable). • Subject is scheduled for simultaneous bilateral hip replacement surgery. • Subject has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing of informed consent for the present study. • Subject has previously participated in a clinical trial with YM150.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The diagnosis of DVT will be confirmed if the symptoms and physical examination findings of the affected leg are compatible with DVT and one of the following two tests confirms the diagnosis: Compression ultrasonography compatible with intraluminal clot; Abnormal venogram (i.e. intraluminal filling defects). Measure:Incidence of proximal or distal DVT Symptomatic DVT (proximal and distal) Timepoints:Day 12 ; Outcome name:It will be evaluated clinically during the study Measure:Incidence of death from all causes Timepoints:12 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Proximal DVT, symptomatic DVT, PE and Death from all causes Measure:Major VTE Incidence Timepoints:12 days ; Outcome name:DVT, PE and death related to VTE Measure:Total VTE Incidence Timepoints:12 days ; Outcome name:The diagnosis will be confirmed if the symptoms and physical examination findings of the affected leg are compatible with DVT and one of the following two tests confirms the diagnosis: Compression ultrasonography compatible with intraluminal clot; Abnormal venogram (i.e. intraluminal filling defects). Measure:Total, proximal and distal DVT Timepoints:12 days ; Outcome name:Helical computed tomography (CT) is abnormal (for example, intraluminal filling defect in the segmental or more proximal branches); Ventilation-perfusion (VQ) scanning is abnormal [for example, a perfusion defect of at least 75% of a segment with normal local ventilation (high probability)]; Pulmonary angiogram is abnormal (i.e. an intraluminal filling defect or a sudden cut of blood vessels larger than 2.5 mm in diameter). Measure:PE incidence Timepoints:12 days | — |
Countries
Austria, Czech Republic, Denmark, Estonia, Finland, Germany, Hungaria, Italy, Latovia, Lithuania, Netherlands, Slovakia, Spain, Sweden, United Kindgdom
Outcome results
None listed