Medically Ill Patient Assessment of Rivaroxaban Versus Placebo IN Reducing Post-Discharge Venous Thrombo-Embolism Risk (MARINER)
DescriptionRATIONALE: The risk of developing venous thromboembolism is a major cause of morbidity in the hospitalized population. Current therapies such as heparin often have a narrow therapeutic index meaning if you don't give exactly the right doses in the therapeutic range, the patient is at risk of severe bleeding and possible mortality. Rivaroxaban is an oral, direct acting Factor Xa inihibitor anticoagulant that posseses a wider therapeutic index which reduces the risk of adverse bleeding. The rationale of this study is to compare the efficacy and safety of rivaroxaban in preventing venous thromboembolism and related deaths compared to placebo group after discharge in the high-risk medically ill population. INTERVENTION: Experiment group will receive rivaroxaban for 45 days and standard therapy. The placebo group will receive standard therapy only. OBJECTIVES: The primary objective is to assess the efficacy and safety of rivaroxaban, compared with placebo in the prevention of symptomatic VTE and VTE-related death posthospitaldischarge in high-risk, medically ill patients.STUDY POPULATION: Approximately 8000 subjects worldwide who are 40 years of age or older and hospitalized for at least 3 days with diagnoses of one of the following: congestive heart failure, acute respiratory insufficiency, acute exacerbation of chronic obstructive pulmonary disease, acute ischemic stroke, acute infectious disease, or inflammatory disease including rheumatic disease.STUDY METHODOLOGY: This is a multicenter, prospective, randomized, double-blind, placebo-controlled, event-driven study designed to evaluate rivaroxaban, compared with placebo, in the prevention of symptomatic VTE events and VTE-related deaths for a period of 45 days posthospital discharge. Study drug will start at randomization (Day 1), and will continue until Day 45 (inclusive).STUDY ENDPOINTS:The primary efficacy outcome is the composite of all symptomatic VTE events (lower extremity DVT, non-fatal PE) and VTE-related deathSTATISTICS: Key Analysis Set and Analysis Phase Intention-to-Treat (ITT): This analysis set consists of all randomized subjects who have a signed valid informed consent. Up-to-Day-45: This analysis phase includes all data from randomization to Day 45 (inclusive).
PhasePhase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.
Inclusion and Exclusion 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
- 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
Please contact Melissa Minor to learn more about where you can participate in this trial. Please use the contact form on the right side.