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NAVIGATE ESUS


Title Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS) comparing rivaroxaban 15 mg once daily with aspirin 100 mg
Therapeutic Area Stroke
Principal Investigator David E. Thaler, MD, PhD
Min Age 18 Years
Gender Both
Contact Haley Huggins
617-636-7606
More Information http://clinicaltrials.gov/ct2/show/NCT02313909

Overview

The purpose of this study is to find out whether a new anti-clotting medication called rivaroxaban leads to fewer blood clots in your brain (stroke) or in other blood vessels in your body when compared with aspirin.

Study Details

Inclusion Criteria

  • Embolic stroke of undetermined source
  • Stroke occurs between 7 days and 6 months of signed consent
  • Informed consent

Exclusion Criteria

  • Severely disabling stroke (mRS ≥ 4)
  • Patent foramen ovale (PFO) with plans for closure
  • Known serious infection or inflammatory disease

Study Requirements

There is no fixed duration of the study. It is estimated that a patient may be in the study for 1 to 3 years or even longer, if the study runs longer. A patient will be assigned to either aspirin or rivaroxaban. The patient will have to come back to the clinic after 1 month and 6 months and then every 6 months until the end of the study. The patient’s doctor will also call them at 3 months.

Screening visit (1-2 hours)

-          10 mL (2 teaspoons) of blood will be taken to measure the patient’s kidney function.

-          Pregnancy test (if applicable)

-          Informed consent

Randomization visit  (same day as screening, approximately 1 hour)

-          Assigned either aspirin or rivaroxaban

-          Complete questionnaires

Regular Study visits

-          Collect information about any new medical problems

-          Complete questionnaires

-          Check vitals

-          Resupply drug

End of Treatment visit

-          Collect information about any new medical problems

-          Patient must bring their medication bottle

-          Complete questionnaires

Check vitals