MARINER Study

Condition/Intervention

  • Venous thromboembolism


Study Name

Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk (MARINER)


Phase

Phase 3


Summary

The purpose of this study is to test the investigational use of a drug called rivaroxaban. Researchers will compare the effects of rivaroxaban to those of placebo for the prevention of venous thromboembolism (VTE) in high risk, medically ill patients after discharge from hospitalization. VTE is a condition that includes both deep vein thrombosis and pulmonary embolism.

Rivaroxaban is approved by the U.S. Food and Drug Administration (FDA) for the prevention of VTE in patients undergoing elective hip and knee replacement surgery as well as other conditions, but it is not approved by the FDA for the use in the prevention of VTE after the treatment of an acute medical illness.

Financial disclosure: Victor Tapson, MD, is a paid consultant for the company sponsoring this study.


Key Inclusion Criteria

  • At least 40 years of age
  • The duration of the hospitalization must have been at least three and no more than 14 consecutive days.
  • The reason for the hospitalization must have been a new diagnosis or exacerbation of specific medical conditions.
  • Must be an inpatient at Cedars-Sinai


Key Exclusion Criteria

  • Pregnancy
  • Any bleeding that would contraindicate the use of pharmacologic thromboprophylaxis
  • Any planned major surgery or major invasive diagnostic procedure intended during the duration of the trial
  • Active cancer or known HIV infection

Please see complete list of inclusion and exclusion criteria.


Principal Investigator

Victor Tapson, MD


Co-Investigator

Jeremy Falk, MD


Study Coordinator and Contact

Susan Jackman
Phone: 310-423-4765
Email: susan.jackman@cshs.org


Status

Active


IRB No.

35773


Date Last Updated

08/15