A study to evaluate the efficacy and safety of Rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) in medically ill patients.
- Conditions
- Prevention of symptomatic venous thromboembolism (VTE) and VTE-related death posthospital discharge in high-risk, medically ill patients.MedDRA version: 19.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-000305-13-DE
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12000
•The duration of the index hospitalization must have been at least 3 and no more than 10 consecutive days
•Must meet venous thromboembolism (VTE) risk criteria with a total modified Improve VTE Risk Score of: greater than or equal 4, or 3 with D-dimer > 2*upper limit of normal (ULN), or 2 with D-dimer > 2*ULN
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8600
•Any serious bleeding within 3 months prior to randomization or occurring during index hospitalization
•Serious trauma within 4 weeks before randomization
•History of hemorrhagic stroke at any time in the past
•Severe head trauma within 4 weeks of randomization
•Any medical condition that requires chronic use of any parenteral or oral anticoagulation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method