None listed
Conditions
Interventions
Subjects will be randomly assigned to 1 of 2 treatment groups based on a computer-generated randomization schedule prepared before the study under the supervision of the sponsor.Treatment groups in th
30 and <50 mL/min) or matching placebo daily.All subjects should take study drug (rivaroxaban or placebo) daily with or without food at approximately the same time each day, and discontinue study drug
Sponsors
Janssen Research & Develoment, LLC,
Eligibility
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: a. Subject must be a man or woman, ≥40 years of age. b. The duration of the index hospitalization must have been at least 3 and no more than 10 consecutive days. c. The reason for the index hospitalization must have been a new diagnosis or exacerbation of 1 of the following medical conditions: (please see the protocol).c The subject must be at increased risk for VTE by the total modified IMPROVE VTE Risk Score (Table 1; modified from Spyropoulos37) assessed at screening and verified at randomization .d Life expectancy of at least 3 months. E Prescribed thromboprophylaxis (according to ACCP guidelines)20 with UFH or LMWH (eg, dalteparin and enoxaparin) not exceeding 15,000 U on any given day for UFH and not exceeding 5,000 U on any given day for LMWH. F. Each subject must sign an informed consent form (ICF) . .FOR MORE DETAILS PLEASE SEE THE PROTOCOL
Exclusion criteria
Exclusion criteria: A. Any bleeding (defined as bleeding requiring hospitalization, transfusion, surgical intervention, invasive procedures, occurring in a critical anatomical site, or causing disability) within 3 months prior to randomization or occurring during index hospitalization. BMajor surgery, biopsy of a parenchymal organ, ophthalmic surgery (excluding cataract surgery), or serious trauma (including head trauma) within 4 weeks before randomization. C.Any planned major surgery (see exclusion criterion #2.3) or major invasive diagnostic procedure intended during the duration of the trial.D.Subjects with any known coagulopathy or bleeding diathesis, or an INR >1.5 during the index hospitalization .E.A history of hemorrhagic stroke or any intracranial bleeding at any time in the past, evidence of primary intracranial hemorrhage on CT or magnetic resonance imaging scan of the brain, or clinical presentation consistent with intracranial hemorrhage. This applies as well to subjects hospitalized for ischemic stroke upon randomization.F. Subject has a history of or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous (AV) malformation, or aneurysm. G.Active gastroduodenal ulcer, defined as diagnosed within 3 months or currently symptomatic or known AV malformations of the gastrointestinal tract. H.Screening platelet count <75 x 109 cells/L. FOR MORE DETAILS PLEASE SEE THE PROTOCOL
Countries
Argentina, Australia, Austria, Belarus, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Macedonia, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Turkey, Ukraine, United Kindgdom, United States, Yugoslavia
Contacts
Public ContactBertha del Pilar Cabrera
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed