COMPLETEDResults postedPhase 3

A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

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.

Sponsor

Janssen Research & Development, LLC

Enrollment

12,024 participants

Sites

593 locations

Start Date

January 2014

Completion

March 2018

Heart FailureRespiratory InsufficiencyStroke AcuteInfectious DiseasesRheumatic Diseases

Enrollment & Timeline

Completed

Target N

12,024

participants

Sites

593

locations

Duration

4.3 years

total trial span

Rate

231

pts/month needed

At 593 sites, each site needs to enroll approximately 0.4 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE. Design, rationale, and clinical implications.

Raskob Gary E, Spyropoulos Alex C, Zrubek Julie et al.Thrombosis and haemostasis2018

DOI PubMed

Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness.

Spyropoulos Alex C, Ageno Walter, Albers Gregory W et al.The New England journal of medicine2018

DOI PubMed

Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials.

Weitz Jeffrey I, Raskob Gary E, Spyropoulos Alex C et al.Thrombosis and haemostasis2020

DOI PubMed

Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients.

Spyropoulos Alex C, Ageno Walter, Albers Gregory W et al.Journal of the American College of Cardiology2021

DOI PubMed

Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups.

Jamil Adeel, Jamil Umer, Singh Kamaldeep et al.Critical pathways in cardiology2021

DOI PubMed

Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER.

Raskob Gary E, Spyropoulos Alex C, Spiro Theodore E et al.Journal of the American Heart Association2022

DOI PubMed

Association of Bleeding Severity With Mortality in Extended Thromboprophylaxis of Medically Ill Patients in the MAGELLAN and MARINER Trials.

Spyropoulos Alex C, Raskob Gary E, Cohen Alexander T et al.Circulation2022

DOI PubMed

Benefit-Risk Assessment of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness.

Raskob Gary E, Ageno Walter, Albers Gregory et al.Journal of the American Heart Association2022

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

COMPLETEDResults postedPhase 3

A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

Sponsor

Janssen Research & Development, LLC

Enrollment

12,024 participants

Sites

593 locations

Start Date

January 2014

Completion

March 2018

Heart FailureRespiratory InsufficiencyStroke AcuteInfectious DiseasesRheumatic Diseases

Enrollment & Timeline

Completed

Target N

12,024

participants

Sites

593

locations

Duration

4.3 years

total trial span

Rate

231

pts/month needed

At 593 sites, each site needs to enroll approximately 0.4 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE. Design, rationale, and clinical implications.

Raskob Gary E, Spyropoulos Alex C, Zrubek Julie et al.Thrombosis and haemostasis2018

DOI PubMed

Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness.

Spyropoulos Alex C, Ageno Walter, Albers Gregory W et al.The New England journal of medicine2018

DOI PubMed

Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials.

Weitz Jeffrey I, Raskob Gary E, Spyropoulos Alex C et al.Thrombosis and haemostasis2020

DOI PubMed

Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients.

Spyropoulos Alex C, Ageno Walter, Albers Gregory W et al.Journal of the American College of Cardiology2021

DOI PubMed

Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups.

Jamil Adeel, Jamil Umer, Singh Kamaldeep et al.Critical pathways in cardiology2021

DOI PubMed

Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER.

Raskob Gary E, Spyropoulos Alex C, Spiro Theodore E et al.Journal of the American Heart Association2022

DOI PubMed

Association of Bleeding Severity With Mortality in Extended Thromboprophylaxis of Medically Ill Patients in the MAGELLAN and MARINER Trials.

Spyropoulos Alex C, Raskob Gary E, Cohen Alexander T et al.Circulation2022

DOI PubMed

Benefit-Risk Assessment of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness.

Raskob Gary E, Ageno Walter, Albers Gregory et al.Journal of the American Heart Association2022

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC)

Up to Day 45

Symptomatic VTE included lower extremity deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE). Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC

From randomization to 2 days after the last dose (Day 45)

A major bleeding event was defined using validated International Society on Thrombosis and Haemostasis (ISTH) bleeding criteria. A major bleeding event was defined as overt bleeding that was associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or a critical site defined as intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or a fatal outcome. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or last dose + 2 days.

Eligibility

Min Age

40 Years

Sex

all

Healthy Volunteers

View full 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

Ask AI

A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (593)