None listed
Conditions
Interventions
Group 1 Type of group
Enoxaparin 40 mg SC once a day for 10 ± 4 days + rivaroxaban placebo
Group name:Group 2 Type of group
rivaroxaban 10 mg orally (PO) once a day for 35 ± 4 days. + enoxaparin placebo
Sponsors
BAYER S.A.,
Eligibility
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Male and female patients 40 years old and over • Patients at risk of venous thromboembolic events hospitalized for acute clinical conditions such as: NYHA Class III or IV heart failure, active cancer (for example, internal to chemotherapy or to treat a complication of active cancer), acute ischemic stroke ( documented) with paresis opalescence in feet and inability to walk without assistance, acute infection, acute respiratory failure, acute rheumatic disorders, acute inflammatory bowel disease, diabetes mellitus (eg, diabetic ketoacidosis, hyperosmolar coma), pancreatitis (unplanned surgical management) , cholecystitis (surgical management not planned), Other. • Full anticipated immobilization during the first day of hospitalization and anticipated reduction of the level of mobility (bed rest) and length of stay of at least 4 days. • Hospitalized for less than 48 hours before randomization, • Written informed consent of the patient for participation after receiving detailed written and oral information before any specific procedure of the study.
Exclusion criteria
Exclusion criteria: • Conditions that contraindicate the use of antithrombotic therapy with the LMWH enoxaparin. • Conditions that may increase the risk of bleeding, including intracranial hemorrhage, such as: - Clinically significant bleeding within 30 days of randomization. - Platelet count 1.5 at the time of selection unrelated to VKA therapy. - History of hemorrhagic stroke at any time in the past, evidence of primary intracranial hemorrhage on a CT or brain MRI, or consistent clinical presentation with intracranial hemorrhage (eg, severe headache or new neurological deficit subsequent to fibrinolytic therapy). - Recent severe head trauma within 30 thirty days of randomization including concussion, cranial foot-act or hospitalization for cephalic injury - Known intracranial neoplasia, brain metastasis, arteriovenous malformation or aneurysm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:detected by obligatory venous ultrasound of both lower extremities on Day 35 ± 4 days Measure:DVT of the lower extremity, proximal, asymptomatic, symptomatic lower extremity (proximal or distal) Timepoints:Day 35 ± 4 days ; Outcome name:Symptomatic non-fatal PE and Death related to VTE until Day 35 ± 4 days. Measure:Symptomatic non-fatal PE and Death related to VTE until Day 35 ± 4 days. Timepoints:Day 35 ± 4 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Incidence of VTE (DVT or EP) symptomatic until Day 35 ± 4 days. Measure:Incidence of VTE (DVT or EP) symptomatic until Day 35 ± 4 days. Timepoints:Day 35 ± 4 days. ; Outcome name:Incidence of each of the components of the primary efficacy evaluation parameter. Measure:Incidence of each of the components of the primary efficacy evaluation parameter. Timepoints:Day 35 ; Outcome name:Incidence of symptomatic VTE until Day 90 ± 7 days. Measure:Incidence of symptomatic VTE until Day 90 ± 7 days. Timepoints:Day 90 ± 7 days. ; Outcome name:Incidence of mortality for all causes up to Day 90 ± 7 days. Measure:Incidence of mortality for all causes up to Day 90 ± 7 days. Timepoints:Day 90 ± 7 days. ; Outcome name:Incidence of cardiovascular death compound, acute myocardial infarction or acute ischemic stroke until Day 35 ± 4 days. Measure:Incidence of cardiovascular death compound, acute myocardial infarction or acute ischemic stroke until Day 35 ± 4 days. Timepoints:Day 35 ± 4 days. ; Outcome name:Incidence of cardiovascular death compound, acute myocardial infarction or acute ischemic stroke until Day 90 ± 7 days. Measure:Incidence of cardiovascular death compound, acute myocardial infarction or acute ischemic stroke until Day 90 ± 7 days. Timepoints:Day 90 ± 7 days. ; Outcome name:assessed by the composite evaluation parameter that comprises the evaluation parameter of primary efficacy and major bleeding emerging from treatment or bleeding that is not clinically relevant. Measure:Net clinical benefit Timepoints:Day 35 | — |
Countries
Austria, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latovia, Lithuania, Netherlands, Poland, Portugal, Slovenia, Spain, Sweden, United Kindgdom
Contacts
Public ContactLuis Carlos Razzeto
BAYER S.A.
Outcome results
None listed