Clinical Study

Stroke Prevention Trial Comparing Rivaroxaban To Aspirin At Preventing Another Stroke In Patients Who Recently Had A Stroke Of Undetermined Cause.

Posted Date: Feb 22, 2017

  • Investigator: Dawn Kleindorfer
  • Co-Investigator: Omar Lopez
  • Specialties: Neurosurgery, Stroke, Neurology
  • Type of Study: Drug

The purpose of this study is to compare two drugs in preventing blood clots, rivaroxaban and aspirin. The study drug rivaroxaban/Xarelto® has not yet been approved by the Federal Drug Administration (FDA) for secondary prevention of blood clots in the brain (stroke) and prevention of systemic embolism (blood clot) in patients who have had a recent embolic stroke of undetermined source (ESUS). Rivaroxaban works by directly blocking the action of a blood component called factor Xa. Factor Xa normally causes blood to clot. Rivaroxaban was approved by the FDA in 2008 for the treatment of different diseases such as prevention of stroke caused by an irregular heart rhythm (atrial fibrillation). Aspirin is widely used for treatment of a number of conditions, including fever, pain, and inflammatory disease. It is used to prevent heart attack and stroke. It lowers the risk of having a new stroke. However, in the case of ESUS, the risk is still substantial (3 to 6% per year) even if you take aspirin. Both rivaroxaban and aspirin are a tablet taken by mouth once a day with a meal. The dose of rivaroxaban tested in the study is 15 mg and the dose of aspirin is 100 mg.


We Are Asking You To Take Part In This Research Study Because You Are 18 Years Of Age Or Older And You Have Recently Had A Brain Attack (Also Called A Stroke) Due To A Lack Of Blood Flow To Part Of Your Brain That May Have Been Caused By A Blood Clot. In Your Case, No Clear Cause Of The Stroke Could Be Identified (I.E. Of Undetermined Source). These Strokes Can Also Be Called “Embolic Stroke Of Undetermined Source” And The Abbreviation Is Esus. To Reduce The Risk Of Another Brain Attack (Or Secondary Stroke) You Would Normally Receive A Medication That Slows Clotting. The Most Frequently Used Treatment For This Purpose Is Aspirin. There Are Alternative Treatments And It Is Possible That New Anti-Clotting Drugs Become Available During This Study. Ask Your Doctor If You Would Like More Information Regarding The Potential Risks And Benefits Of These Alternative Treatments.


Cerebrovascular Accident, Rivaroxaban, Stroke, Blood Clot, Aspirin

For More Information:

Alisha Hodge, Rn, Bsn
(513) 558-5149

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