Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Enoxaparin; Enoxaparin sodium; Rivaroxaban

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, New York Heart Association (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:

• Conditions that contraindicate the use of antithrombotic therapy with the Low Molecular-Weight Heparin (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