Multicenter, Randomized, Active-Controlled Efficacy and Safety Study Comparing Extended Duration Betrixaban With Standard of Care Enoxaparin for the Prevention of Venous Thromboembolism in Acute Medically Ill Patients
DescriptionThe purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.
PhasePhase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.
Inclusion and Exclusion Criteria
- men and non-pregnant, non-breastfeeding women
- anticipated to be severely immobilized for at least 24 hours after randomization
- hospitalized with one of the following
- congestive heart failure
- acute respiratory failure,
- acute infection without septic shock,
- acute rheumatic disorders
- acute ischemic stroke with lower extremity hemiparesis or hemi paralysis
- a condition requiring prolonged anticoagulation or anti-platelets
- active bleeding or at high risk of bleeding
- contraindication to anticoagulant therapy
- general conditions in which subjects are not suitable to participate in the study
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.