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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Infectious Diseases; Respiratory Insufficiency; Stroke Acute; Heart Failure; Rheumatic Diseases

Treatments: Drug: Placebo; Drug: Rivaroxaban, 10 mg; Drug: Rivaroxaban, 7.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02111564

RIVAROXDVT3002 (Other Identifier)

2014-000305-13 (EudraCT Number)

CR103834

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12,024 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12,024 participants in 2 patient groups, including a placebo group

Rivaroxaban

Experimental group

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.

Treatment:

Drug: Rivaroxaban, 7.5 mg

Drug: Rivaroxaban, 10 mg

Placebo

Placebo Comparator group

Description:

Each patient will receive matching placebo tablet once daily orally (by mouth) for 45 days.

Treatment:

Drug: Placebo