MARINER
Research type
Research Study
Full title
Medically III Patient Assessment of Rivaroxaban Versus Placebo IN Reducing Post-Discharge Venous Thrombo-Embolism Risk (MARINER)
IRAS ID
192710
Contact name
Jessica Bainbridge
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2014-000305-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 29 days
Research summary
Venous thromboembolism including deep vein thrombosis and pulmonary embolism represents one of the most common health problems and are associated with high mortality and considerable morbidity.
Medically ill patients, ie, patients that are hospitalised for the treatment of acute medical illnesses, are at high risk for the development of venous thromboembolism during their hospital stay and immediately after their hospital discharge. Parenteral anticoagulation is recommended for thromboprophylaxis in hospitalised medically ill patients during the hospital stay, but not recommended after discharge. While continued thromboprophylaxis with parenteral agents post discharge could potentially reduce the overall risk of VTE, this approach has not yet been widely used.
Previous studies have not provided enough evidence that the benefit to be gained from giving medically ill patients extended anticoagulation medication outweighed the increased risk of bleeding. In line with this data, international guidelines do not recommend routine prescribing of VTE prophylaxis for medically ill patients discharged from hospital.
When the MARNER Study is complete, the study team hopes that the results will establish extended thromboprophylaxis in discharged medically ill patients as new standard of care.
The proposed study is designed to evaluate rivaroxaban, compared with placebo, in the prevention of symptomatic VTE events and VTE-related deaths for a period of 45 days post-hospital discharge in participants ≥40 years of age who have been hospitalised for a specific acute medical illness and who have other risk factors for VTE.
Participants will be randomly assigned to receive rivaroxaban or placebo. After randomisation, they will receive double-blind treatment with rivaroxaban daily or matching placebo daily. The study is double blinded meaning that neither the participant nor the study doctor will know which treatment is being given.
This study is sponsored by the pharmaceutical company, Janssen Research & Development, LLC.
This is a multicentre study which will take place worldwide. It is anticipated that around 9000 participants will be enrolled, with 70 from the UK.REC name
HSC REC A
REC reference
16/NI/0036
Date of REC Opinion
27 Apr 2016
REC opinion
Further Information Favourable Opinion