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

TerminadoFase 3ClinicalTrials.gov

ID: NCT02313909Tipo: INTERVENTIONALInicio: 23 de dic de 2014Fin estimado: 15 de feb de 2018

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

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)

Criterios de exclusión

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

Intervenciones

drug

Rivaroxaban (Xarelto, BAY59-7939)

15 mg, once daily, orally, tablet

drug

Acetylsalicylic acid (Aspirin, BAY1019036)

100 mg, once daily, orally, tablet

other

Rivaroxaban-Placebo

Matching placebo, once daily, orally, tablet

other

Aspirin-Placebo

Matching placebo, once daily, orally, tablet

Ubicaciones

Banfield, Buenos Aires, Argentina

Ciudad Auton. de Buenos Aires, Buenos Aires, Argentina

Mar del Plata, Buenos Aires, Argentina

San Martín, Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Rosario, Santa Fe Province, Argentina

Ciudad Auton. de Buenos Aires, Argentina

Córdoba, Argentina

Santa Fe, Argentina

Patrocinadores

PrincipalBayer

ColaboradorJanssen Research & Development, LLC

ColaboradorPopulation Health Research Institute

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