Trial Purpose and Description
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.
Ages: 18 years and older
- Recent ESUS (between 7 days and 6 months), defined as:
- Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar, and
- Absence of cervical carotid atherosclerotic stenosis ≥ 50% or occlusion, and
- No atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring, and
- No intra-cardiac thrombus on transthoracic echocardiography, and
- No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)
- Severely disabling stroke (modified Rankin score ≥4)
- Indication for chronic anticoagulation or antiplatelet therapy
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
Bayer Healthcare Pharmaceuticals, Inc.
Dates: 08/29/2015 - 01/31/2018
Last Updated: 02/23/2016
Study HIC#: 1505015783