Last updated on May 2018

Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)

Brief description of study

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

Detailed Study Description

The decision to terminate the study due to no efficacy improvement over aspirin at an interim analysis and very little chance of showing overall benefit if study was completed was taken in September and communicated via press release. For transparency purpose, we communicated this status on however, few patients remained in the study for follow up, and there is no completion date yet. Therefore, we updated the status back to "active, not recruiting", till all data regarding patient in follow up have been collected and we can provide a completion date.

Clinical Study Identifier: NCT02313909

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Altenburg, Germany