Health Condition 1: null- Venous Thromboembolism
Conditions
Interventions
Intervention1: Rivaroxaban (BAY 59-7939): Drug: Rivaroxaban (Xarelto, BAY59-7939)
Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days
Drug: Enoxaparin placebo
Subcutaneous enoxaparin-ma
Sponsors
Bayer
Johnson Johnson Pharmaceutical Research Development LLC
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - Male and female patients aged 40 years or more - Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows: -Heart failure, NYHA class III or IV -Active cancer -Acute ischemic stroke -Acute infectious and inflammatory diseases, including acute rheumatic diseases -Acute respiratory insufficiency - Additional risk factor for VTE, including reduced mobility
Exclusion criteria
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 - Required drugs or procedures which may interfere with the study treatment - Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome - General conditions in which subjects are not suitable to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of VTE (DVT and/or PE) and DeathTimepoint: Time Frame: up to day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual components of the composite endpoint and other cardiovascular events.Timepoint: Time Frame: 90 + 7 days | — |
Countries
India
Contacts
Public ContactDr Ashish Gawde
Outcome results
None listed