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

Bayer

Status and phase: Terminated; Phase 3

Conditions: Stroke

Treatments: Other: Aspirin-Placebo; Other: Rivaroxaban-Placebo; Drug: Acetylsalicylic acid (Aspirin, BAY1019036); Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02313909

2013-000768-27 (EudraCT Number)

16573

Details and patient eligibility

About

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.

Enrollment: 7,213 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7,213 participants in 2 patient groups

Rivaroxaban

Experimental group

Description:

Rivaroxaban 15 mg orally once daily

Treatment:

Other: Rivaroxaban-Placebo

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Aspirin

Active Comparator group

Description:

Aspirin 100 mg orally once daily

Treatment:

Other: Aspirin-Placebo

Drug: Acetylsalicylic acid (Aspirin, BAY1019036)