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



Status:Terminated
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:50 - Any
Updated:1/11/2019
Start Date:December 23, 2014
End Date:February 15, 2018

Use our guide to learn which trials are right for you!

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

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.


Inclusion Criteria:

- 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 either transesophageal or transthoracic echocardiography,
and

- No other specific cause of stroke (for example, arteritis, dissection,
migraine/vasospasm, drug abuse)

Exclusion Criteria:

- Severely disabling stroke (modified Rankin score ≥4)

- Indication for chronic anticoagulation or antiplatelet therapy

- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2
We found this trial at
43
sites
1009
mi
from 43215
Temple, TX
Click here to add this to my saved trials
164
mi
from 43215
Ann Arbor, MI
Click here to add this to my saved trials
1069
mi
from 43215
Austin, TX
Click here to add this to my saved trials
344
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
5395
mi
from 43215
Banfield,
Click here to add this to my saved trials
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
294
mi
from 43215
Buffalo, NY
Click here to add this to my saved trials
Charleston, South Carolina 29412
527
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
98
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
426
mi
from 43215
Columbia, SC
Click here to add this to my saved trials
910
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
1425
mi
from 43215
El Paso, TX
Click here to add this to my saved trials
212
mi
from 43215
Erie, PA
Click here to add this to my saved trials
711
mi
from 43215
Gainesville, FL
Click here to add this to my saved trials
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
460
mi
from 43215
Iowa City, IA
Click here to add this to my saved trials
288
mi
from 43215
Joliet, IL
Click here to add this to my saved trials
154
mi
from 43215
Lexington, KY
Click here to add this to my saved trials
1975
mi
from 43215
Long Beach, CA
Click here to add this to my saved trials
182
mi
from 43215
Mount Clemens, MI
Click here to add this to my saved trials
331
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
New Brunswick, New Jersey 08901
453
mi
from 43215
New Brunswick, NJ
Click here to add this to my saved trials
537
mi
from 43215
New Haven, CT
Click here to add this to my saved trials
798
mi
from 43215
New Orleans, LA
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
2026
mi
from 43215
Portland, OR
Click here to add this to my saved trials
2026
mi
from 43215
Portland, OR
Click here to add this to my saved trials
1513
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
2100
mi
from 43215
Stanford, CA
Click here to add this to my saved trials
1983
mi
from 43215
Torrance, CA
Click here to add this to my saved trials
1639
mi
from 43215
Tucson, AZ
Click here to add this to my saved trials
604
mi
from 43215
Worcester, MA
Click here to add this to my saved trials