Trial record 1 of 1 for:
NCT02111564
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 |
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Recruitment Status :
Completed
First Posted : April 11, 2014
Last Update Posted : October 15, 2018
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Sponsor:
Janssen Research & Development, LLC
Collaborator:
Bayer
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure Respiratory Insufficiency Stroke Acute Infectious Diseases Rheumatic Diseases | Drug: Rivaroxaban, 10 mg Drug: Rivaroxaban, 7.5 mg Drug: Placebo | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 12025 participants |
| 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 |
| Actual Study Start Date : | January 7, 2014 |
| Actual Primary Completion Date : | May 3, 2018 |
| Actual Study Completion Date : | May 3, 2018 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Rivaroxaban
| Arm | Intervention/treatment |
|---|---|
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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.
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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 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 less than (<)50 mL/min will receive 7.5 mg rivaroxaban tablet with or without food.
Other Name: Xarelto, BAY59-7939 |
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Placebo Comparator: Placebo
Each patient will receive matching placebo tablet once daily orally (by mouth) for 45 days.
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Drug: Placebo
All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food. |
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 the first occurrence of a composite of symptomatic VTE, myocardial infarction (MI), non-hemorrhagic stroke, and cardiovascular (CV) death [ Time Frame: From Day 1 up to Day 45 ]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 is considered a CV death) will be reported.
- Time from randomization to an occurrence of ACM [ 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111564
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Sponsors and Collaborators
Janssen Research & Development, LLC
Bayer
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 ) |
| First Posted: | April 11, 2014 Key Record Dates |
| Last Update Posted: | October 15, 2018 |
| Last Verified: | October 2018 |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Janssen Research & Development, LLC:
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Heart Failure Respiratory Insufficiency Stroke Acute Infectious Diseases Rheumatic Diseases |
Medically ill Patient Rivaroxaban Thromboembolism Prophylactic Anti-Coagulation |
Additional relevant MeSH terms:
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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 |