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NAVIGATE-ESUS: Secondary prevention of stroke in patients with a recent ESUS

Sponsor: Bayer
Principal investigator: Carlos Kase MD
Sub-investigators: Viken Babikian MD, Thanh Nguyen MD, Jose Romero MD, Hesham Masoud MD, Hugo Aparicio MD

Summary: Worldwide, 16 million people suffer a first ever stroke annually and 25% of all ischemic strokes are recurrent strokes. The ischemic stroke recurrence rate is substantial and remains at 3 to 6% per year during ASA treatment, the standard guideline recommended antithrombotic therapy for secondary prevention in most patients without major-risk cardioembolic causes. No specific treatment has been tested for patients with embolic stroke of undetermined source (ESUS). Only recently have insights into this disease revealed that most of these strokes are due to embolism. Data from the WARSS study and clinical trials with oral anticoagulants in patients with non-valvular atrial fibrillation support that anticoagulation is likely to be the better treatment option for embolic stroke compared with antiplatelet therapy.

Purpose: To evaluate whether rivaroxaban is superior to aspirin in reducing the risk of recurrent stroke and systemic embolism in patients with a recent ESUS.

Inclusion Criteria (highlights only):

  • Embolic stroke of undetermined source (ESUS)
  • Time from recent ischemic stroke to randomization and first study medication intake between 7 days and 6 months except (with some exceptions).
  • Age ≥18 years
  • For patients with age < 60 years at least one of the following risk factors: stroke or TIA prior to index stroke, diabetes, hypertension, and heart failure

Status: Actively enrolling patients