Phase 3
Completed 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
Source: ClinicalTrials.gov NCT02111564 ↗
Enrolled (actual)
12,019
Serious AEs
8.1%
Results posted
Nov 2019
Primary outcomePrimary: 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
◆ Published Evidence
Established
63citations · ~11 / year
Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients.
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.
Linked Publications (5)
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Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients.
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Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER.
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Benefit-Risk Assessment of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness.
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Association of Bleeding Severity With Mortality in Extended Thromboprophylaxis of Medically Ill Patients in the MAGELLAN and MARINER Trials.
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Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups.
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 |
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) and the linked publication. 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. Informational only — not medical advice.