Current Studies

STUDY DESIGN & POPULATION

Multicenter, prospective, randomized, double-blind, placebo-controlled, event-driven study of men and women age ≥40 years old who have been hospitalized for the new onset or exacerbation of one of the following:

• Heart Failure (HF) with a reduced left ventricular ejection fraction (LVEF ≤45%)
• Acute respiratory insufficiency or acute exacerbation of chronic obstructive pulmonary disease (COPD)
• Acute ischemic stroke (including spinal cord infarction if no evidence of intramedullary, subdural or epidural hemorrhage)
• Acute infectious disease
• Inflammatory disease, including rheumatic disease
• In order to be eligible, subjects must have an increased VTE risk, as demonstrated by a total modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) VTE Risk Score of:
• ≥4, or
• 3 with D-dimer > 2XULN, or
• 2 with D-dimer > 2XULN

In addition, subjects must have received treatment during the index hospitalization with LMWH or UFH

OBJECTIVE

The primary objective of this study is to assess the efficacy and safety of rivaroxaban, compared with placebo in the prevention of symptomatic VTE (lower extremity DVT and non-fatal PE) and VTE-related death (death due to PE or death in which PE cannot be ruled out as the cause) post-hospital discharge in high-risk medically ill subjects

The secondary objective is to compare rivaroxaban with placebo in the following post-hospital discharge outcomes in high-risk, medically ill patients:

• VTE-related death (death due to PE or death in which PE cannot be ruled out as the cause)
• Symptomatic VTE (lower extremity DVT and non-fatal PE)
• The composite of symptomatic VTE (lower extremity DVT and non-fatal PE) and all-cause mortality (ACM)
• The 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)
• ACM

Exploratory objectives of this study are to compare rivaroxaban with placebo in post-hospital discharge outcomes in these medically-ill, high risk patients. These outcomes include:

• Symptomatic lower extremity DVT
• Symptomatic non-fatal PE
• Symptomatic upper extremity DVT
• Myocardial Infarction (MI)

INTERVENTION

Comparison of placebo and Factor Xa (FXa) inhibitor anticoagulant Rivaroxaban

The proposed MARINER study was designed to improve the overall safety of medically ill patients with rivaroxaban (10 mg daily in subjects with CrCl ≥50 mL/min or 7.5 mg daily in subjects with CrCl of ≥30 to <50 mL/min) treatment for 45 days post-hospital discharge