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Trial record 1 of 1 for:    NCT02111564
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A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients (MARINER)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Janssen Research & Development, LLC
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02111564
First received: March 31, 2014
Last updated: August 25, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention Phase
Heart Failure Respiratory Insufficiency Stroke Acute Infectious Diseases Rheumatic Diseases Drug: Rivaroxaban, 10 mg Drug: Rivaroxaban, 7.5 mg Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Time from randomization to the first occurrence of symptomatic venous thromboembolism event (VTE) and VTE-related death [ Time Frame: From Day 1 up to Day 45 ]
    Symptomatic VTE will include lower extremity deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE).

  • Time from randomization to the first occurrence of major bleeding [ Time Frame: From Day 1 up to Day 45 ]
    Major bleeding will be defined using validated International Society on Thrombosis and Haemostasis (ISTH) bleeding criteria.


Secondary Outcome Measures:
  • Time from randomization to an occurrence of VTE-related death [ Time Frame: From Day 1 up to Day 45 ]
  • Time from randomization to the first occurrence of a symptomatic VTE [ Time Frame: From Day 1 up to Day 45 ]
    Symptomatic VTE will include lower extremity DVT and non-fatal PE.

  • Time from randomization to the first occurrence of a composite of symptomatic VTE and all-cause mortality (ACM) [ Time Frame: From Day 1 up to Day 45 ]
  • Time from randomization to an occurrence of ACM [ Time Frame: From Day 1 up to Day 45 ]
  • Time from randomization to an occurrence of myocardial infarction [ Time Frame: From Day 1 up to Day 45 ]
  • Time from randomization to an occurrence of non-hemorrhagic stroke [ Time Frame: From Day 1 up to Day 45 ]
  • Time from randomization to an occurrence of cardiovascular death [ Time Frame: From Day 1 up to Day 45 ]

Other Outcome Measures:
  • Change in blood plasma concentration of rivaroxaban [ Time Frame: Day 7, Day 21 ]
    At selected sites, blood samples will be collected for pharmacokinetic analysis.


Estimated Enrollment: 12000
Actual Study Start Date: June 2, 2014
Estimated Study Completion Date: May 25, 2018
Estimated Primary Completion Date: May 25, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban
Each patient will receive either 10 mg or 7.5 mg rivaroxaban tablet once daily orally (by mouth) for 45 days. The dosing will depend on a creatinine clearance at screening.
Drug: Rivaroxaban, 10 mg
Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening >= 50 mL/min will receive 10 mg rivaroxaban tablet with or without food.
Other Name: Xarelto, BAY59-7939
Drug: Rivaroxaban, 7.5 mg
Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening from 30 to 49 mL/min will receive 7.5 mg rivaroxaban tablet with or without food.
Other Name: Xarelto, BAY59-7939
Placebo Comparator: Placebo
Each patient will receive matching placebo tablet once daily orally (by mouth) for 45 days.
Drug: Placebo
All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.

Detailed Description:

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect)-controlled, event-driven, multicenter study in patients who are hospitalized for a specific acute medical illness and have other risk factors for venous thromboembolism (VTE). The study is designed to evaluate rivaroxaban in the prevention of symptomatic VTE events and VTE-related deaths for a period of 45 days post-hospital discharge.

The study will consist of a screening phase, a 45-day double-blind treatment phase, and a 30-day follow-up phase. Study drug will start at randomization (Day 1), and will continue until Day 45 (inclusive). A total of approximately 8,000 patients will be randomly assigned to either rivaroxaban or placebo in a 1:1 ratio. The total duration for a patient who completes the study after randomization is expected to be 75 days.

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02111564

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Show 1424 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Bayer
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
Publications:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02111564     History of Changes
Other Study ID Numbers: CR103834
2014-000305-13 ( EudraCT Number )
RIVAROXDVT3002 ( Other Identifier: Janssen Research & Development, LLC )
Study First Received: March 31, 2014
Last Updated: August 25, 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Heart Failure
Respiratory Insufficiency
Stroke Acute
Infectious Diseases
Rheumatic Diseases
Medically ill Patient
Rivaroxaban
Thromboembolism
Prophylactic Anti-Coagulation

Additional relevant MeSH terms:
Heart Failure
Communicable Diseases
Infection
Rheumatic Diseases
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Collagen Diseases
Heart Diseases
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants

ClinicalTrials.gov processed this record on September 19, 2017