Phase 3
N=12,019
A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients
Heart Failure · Respiratory Insufficiency · Stroke Acute · Infectious Diseases · Rheumatic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02111564 ↗Enrolled (actual)
12,019
Serious AEs
8.1%
Results posted
Nov 2019
Primary outcome: Primary: Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC) — 0.84; 1.11 Events per 100 participants in 45 days — p=0.136
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rivaroxaban, 10 mg (Drug); Rivaroxaban, 7.5 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC) |
0.84; 1.11 | 0.136 |
| PRIMARY Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC |
0.28; 0.15 | 0.124 |
| SECONDARY Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC |
0.72; 0.77 | 0.751 |
| SECONDARY Event Rate Based on Time From Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC |
0.19; 0.42 | 0.023 sig |
| SECONDARY Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC |
1.31; 1.80 | 0.033 sig |
| SECONDARY Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC |
1.58; 2.03 | 0.073 |
| SECONDARY Event Rate Based on Time From Randomization to First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC |
1.19; 1.49 | 0.156 |
Summary
The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.
Eligibility Criteria
Key Inclusion Criteria
- 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
Key Exclusion Criteria
- Any serious bleeding within 3 months prior to randomization or occurring during index hospitalization
- Serious trauma (including head trauma) within 4 weeks before randomization
- History of hemorrhagic stroke at any time in the past
- Any medical condition that requires chronic use of any parenteral or oral anticoagulation
Data sourced from ClinicalTrials.gov (NCT02111564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.