Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Apixaban; Enoxaparin

Criteria

Inclusion Criteria:

• men and non-pregnant, non-breastfeeding women

• 40 years or older

• hospitalized with congestive heart failure or acute respiratory failure

• infection (without septic shock)

• acute rheumatic disorder

• inflammatory bowel disease

Exclusion Criteria:

• patients with venous thromboembolism (VTE)

• active bleeding or at high risk of bleeding

• unable to take oral medication

• with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ≤ 165 mg/day.