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: 18.0Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-000305-13-GR
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 8000
•Must be hospitalized at least 3 and no more than 14 consecutive days for an acute medical condition such as congestive heart failure, acute respiratory insufficiency or acute exacerbation of chronic obstructive pulmonary disease, acute ischemic stroke, acute infectious diseases or inflammatory diseases, including rheumatic disease
•Must meet venous thromboembolism (VTE) risk criteria with a total modified Improve VTE Risk Score >=3
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 2700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5300
•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 3 months of randomization
•Any medical condition that requires 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 Main Objective: The primary objective is to assess the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE: lower extremity deep vein thrombosis [DVT] and non-fatal pulmonary embolism [PE]) and VTE-related death post-hospital discharge in high-risk, medically ill patients.;Secondary Objective: The secondary objectives are to compare rivaroxaban with placebo in the following post-hospital<br>discharge outcomes in high-risk, medically ill patients:<br>• VTE-related death<br>• Symptomatic VTE (lower extremity DVT and non-fatal PE)<br>• The composite of symptomatic VTE (lower extremity DVT and non-fatal PE) and all-cause mortality (ACM)<br>• ACM;Primary end point(s): The primary efficacy outcome is the composite of all symptomatic VTE events (lower extremity DVT, non-fatal PE) and VTE-related death.;Timepoint(s) of evaluation of this end point: From randomization up to day 45
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary objectives are to compare rivaroxaban with placebo in the following post-hospital discharge outcomes in high-risk, medically ill patients:<br>- VTE-related death<br>- Symptomatic VTE (lower extremity deep vein thrombosis [DVT] and non-fatal pulmonary embolism [PE])<br>- The composite of symptomatic VTE (lower extremity DVT and non-fatal PE) and all-cause mortality (ACM)<br>- ACM;Timepoint(s) of evaluation of this end point: From randomization up to day 45