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

Recruiting

Phase 3 Results N/A

Trial Description

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 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.

Conditions

Interventions

  • Placebo Other
    Other Names: "Sugar" Pill
    Intervention Desc: All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Each patient will receive matching placebo tablet once daily orally (by mouth) for 45 days.
  • Rivaroxaban, 10 mg Drug
    Other Names: Xarelto, BAY59-7939
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Rivaroxaban
    Description: 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.
  • Rivaroxaban, 7.5 mg Drug
    Other Names: Xarelto, BAY59-7939
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Rivaroxaban
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Time from randomization to the first occurrence of symptomatic venous thromboembolism event (VTE) and VTE-related death From Day 1 up to Day 45 Yes
Primary Time from randomization to the first occurrence of major bleeding From Day 1 up to Day 45 Yes
Secondary Time from randomization to an occurrence of VTE-related death From Day 1 up to Day 45 Yes
Secondary Time from randomization to the first occurrence of a symptomatic VTE From Day 1 up to Day 45 Yes
Secondary Time from randomization to the first occurrence of a composite of symptomatic VTE and all-cause mortality (ACM) From Day 1 up to Day 45 Yes
Secondary Time from randomization to an occurrence of ACM From Day 1 up to Day 45 Yes
Secondary Time from randomization to an occurrence of myocardial infarction From Day 1 up to Day 45 Yes
Secondary Time from randomization to an occurrence of non-hemorrhagic stroke From Day 1 up to Day 45 Yes
Secondary Time from randomization to an occurrence of cardiovascular death From Day 1 up to Day 45 Yes

Sponsors