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

Phase 3: Multicenter, randomized, double-blind study of secondary prevention of stroke & prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS)

Supported by BAYER

Principal Investigator at BMC: Viken Babikian, MD

Study duration: 18+ months

Study drugs: Rivaroxaban 15mg vs aspirin 100mg QD

Inclusion Criteria: Recent ESUS (between 7 days and 6 months), defined as:

  1. Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar, and
  2. Absence of cervical carotid atherosclerotic stenosis > 50% or occlusion, and
  3. No atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring (at least 20 hrs acceptable), and
  4. No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography, and
  5. No other specific cause of stroke (i.e. arteritis, dissection, migraine/vasospasm, drug abuse)

Exclusion criteria:

  1. Severely disabling stroke (modified Rankin score ≥4 at screening)
  2. If imaging of intracranial arteries is performed by CT or MR angiography or transcranial Doppler: > 50% luminal stenosis or occlusion in arteries supplying the area of ischemia
  3. Patent foramen ovale with plans for closure
  4. Known serious infection or inflammatory disease that may be the cause of stroke
  5. Patient has or is intended to receive an implantable ECG loop recorder
  6. Indication for chronic anticoagulation (e.g., patient with prosthetic mechanical valve, venous thromboembolism, hypercoagulable state)
  7. Indication for chronic antiplatelet therapy or chronic therapy with NSAID for a non-stroke indication
  8. Hypersensitivity or other contraindication for ASA or rivaroxaban
  9. Active bleeding, major bleeding within last 6 months, high risk for serious bleeding contraindicating anticoagulant or antiplatelet therapy or history of primary intracranial hemorrhage
  10. Hepatic disease associated with coagulopathy (PTT>normal range) and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
  11. Estimated GFR< 30 mL/min/1.73 m2 as assessed at local laboratory within 1 month of screening
  12. Life expectancy less than 6 months
  13. Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e., human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, or posaconazole, if used systemically
  14. Female of childbearing potential who are not surgically sterile, or, if sexually active not willing to use adequate contraceptive measures, and pregnant or breast feeding women
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