Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement

Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement: A Randomized, Enoxaparin-controlled, Open Label, Dose-escalation Study

Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery

Inclusion Criteria:

• Scheduled for elective primary total knee replacement surgery
• Legal minimum age requirement ( country-specific)
• Written informed consent has been obtained

Exclusion Criteria:

• Documented history or considered to be at increased risk of venous thromboembolism

• Subjects considered to be at increased risk of bleeding:

  • Known hemorrhagic disorder and/or coagulation disorder
  • Thrombocytopenia
  • Clinically important bleeding occurred within 3 months prior to the screening visit

• Acute bacterial endocarditis

• Severe hypertension

• Retinopathy

• Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.