TerminatedPhase 3

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

Stopped: Study halted early due to no efficacy improvement over aspirin at an interim analysis and very little chance of showing overall benefit if study were completed

United States7,213 participantsStarted 2014-12-23

Plain-language summary

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.

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence Rate of the Composite Efficacy Outcome (Adjudicated)

Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)

Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Trial details

NCT IDNCT02313909

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-02-15

Results submitted2018-11-20

View on ClinicalTrials.gov More Stroke trials

Plain-language summary

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence Rate of the Composite Efficacy Outcome (Adjudicated)

Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)

Timeframe: From randomization until the efficacy cut-off date (median 326 days)