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

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ClinicalTrials.gov Identifier: NCT02111564
Recruitment Status : Completed
First Posted : April 11, 2014
Results First Posted : November 25, 2019
Last Update Posted : November 25, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE March 31, 2014
First Posted Date  ICMJE April 11, 2014
Results First Submitted Date  ICMJE November 5, 2019
Results First Posted Date  ICMJE November 25, 2019
Last Update Posted Date November 25, 2019
Actual Study Start Date  ICMJE January 7, 2014
Actual Primary Completion Date March 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC) [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2014)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC [ Time Frame: Up to Day 45 ]
    Event rate based on time from randomization to first occurrence of VTE-related death (adjudicated by CEC) was assessed. 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 a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC [ Time Frame: Up to Day 45 ]
    Event rate based on time from randomization to the first occurrence of a symptomatic VTE (adjudicated by CEC) was assessed. Symptomatic VTE included lower extremity DVT and non-fatal 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 a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC [ Time Frame: Up to Day 45 ]
    Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE and ACM (adjudicated by CEC) was assessed. 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 a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC [ Time Frame: Up to Day 45 ]
    Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE (lower extremity DVT and non-fatal PE), MI, non-hemorrhagic stroke, and CV death (death due to a known CV cause and death in which a CV cause cannot be ruled out; by this definition, a VTE-related death was considered a CV death) as adjudicated by CEC was reported. 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 First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC [ Time Frame: Up to Day 45 ]
    Event rate based on time from randomization to first occurrence of ACM (adjudicated by CEC) was assessed. 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: April 9, 2014)
Change in blood plasma concentration of rivaroxaban [ Time Frame: Day 7, Day 21 ]
At selected sites, blood samples will be collected for pharmacokinetic analysis.
 
Descriptive Information
Brief Title  ICMJE A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients
Official Title  ICMJE Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk
Brief 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.
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 12000 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Heart Failure
  • Respiratory Insufficiency
  • Stroke Acute
  • Infectious Diseases
  • Rheumatic Diseases
Intervention  ICMJE
  • Drug: Rivaroxaban, 10 mg
    Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening greater than or equal to (>=)50 mL/min will receive 10 mg rivaroxaban tablet with or without food.
    Other Names:
    • Xarelto
    • BAY59-7939
  • Drug: Rivaroxaban, 7.5 mg
    Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening from >=30 to less than (<)50 mL/min will receive 7.5 mg rivaroxaban tablet with or without food.
    Other Names:
    • Xarelto
    • BAY59-7939
  • Drug: Placebo
    All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Rivaroxaban, 10 mg
    • Drug: Rivaroxaban, 7.5 mg
  • Placebo Comparator: Placebo
    Each patient will receive matching placebo tablet once daily orally (by mouth) for 45 days.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2019)
12024
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2014)
8000
Actual Study Completion Date  ICMJE May 3, 2018
Actual Primary Completion Date March 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belarus,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Canada,   Colombia,   Croatia,   Czechia,   Denmark,   Estonia,   Georgia,   Germany,   Greece,   Hungary,   Israel,   Latvia,   Lithuania,   Mexico,   Netherlands,   North Macedonia,   Peru,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic,   France,   Italy,   Macedonia, The Former Yugoslav Republic of
 
Administrative Information
NCT Number  ICMJE NCT02111564
Other Study ID Numbers  ICMJE CR103834
2014-000305-13 ( EudraCT Number )
RIVAROXDVT3002 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Bayer
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP