A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalizatio
Phase 3
- Conditions
- thrombosisbloedstolsel10014523
- Registration Number
- NL-OMON33854
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 155
Inclusion Criteria
1) Hospitalized due to
- congestive heart failure
- acute respiratory failure
- infection (without septic shock)
- acute rheumatic disorder
- inflammatory bowel disease
2) Except for subjects with congestive heart failure or respiratory failure subjects must have one additional risk factor for VTE.
3) Expected hospitalisation 3 days or longer after randomisation
4) Severely or moderately restricted mobility
Exclusion Criteria
1) Subjects who received more than 2 days of prophylaxis for VTE
2) Subjects with surgery in the past 30 days
3) Subjects with a condition that requires chronic anticoagulation
4) Subjects with active bleeding or at high risk of bleeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Composite of total VTE and VTE-related death during 30 days of double-blind<br /><br>treatment, where total VTE is defined as the combination of symptomatic deep<br /><br>vein thrombosis, fatal or nonfatal symptomatic pulmonary embolism and<br /><br>asymptomatic proximal deep vein thrombosis detected by compression ultrasound. </p><br>
- Secondary Outcome Measures
Name Time Method <p>*Composite of total VTE, as defined above and VTE-related death occurring up to<br /><br>the time of discontinuation of parenteral therapy.<br /><br>*Composite of total VTE, as defined above and all-cause death at Day 30.<br /><br>*Adjudicated major bleeding events during 30 days of double-blind treatment.<br /><br>*Composite of adjudicated major and clinically relevant non-major bleeding<br /><br>events during 30 days of double-blind treatment.</p><br>