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Completed

NCT Number: NCT02111564

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.

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Key information

Conditions

Heart Failure Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communicable Diseases Connective Tissue Diseases Disease Attributes Embolism and Thrombosis Heart Diseases Infections Infectious Diseases Musculoskeletal Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Stroke Stroke Acute Thromboembolism Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bahía Blanca, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban, 10 mg

Drug

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

Rivaroxaban, 7.5 mg

Drug

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

Placebo

Drug

All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Collaborators

  • Bayer

Registry information

Official study title

Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk

Acronym: MARINER

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 11, 2014
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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