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Clinical Studies – Targeting Acute and Chronic Thromboembolic Disorders
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First Published, Prospective, International, Observational Study of a NOAC in NVAF Patients

Major Studies

 
Objective

  • Evaluate major bleeding and stroke or systemic embolism in NVAF patients in real world clinical settings, ranging from primary care practices to cardiologists’ offices and hospitals
     

Study Design

  • A large, prospective, observational, single-arm, non-interventional study to evaluate the safety and efficacy of Xarelto® in the real world

  • Patients were enrolled from June 2012 to December 2013 from 311 centres in Europe, Canada and Israel
     

Population

  • 6,784 adults with NVAF newly receiving once-daily Xarelto for prevention of stroke and systemic embolism for NVAF were followed for 1 year, or 30 days following permanent treatment discontinuation
     

XANTUS: CHADS2-scores

Xantus
Xantus

AF, atrial fibrillation; CHF, congestive heart failure; CrCl, creatinine clearance; LVEF, left ventricular ejection fraction; NVAF, non-valvular atrial fibrillation; TIA, transient ischaemic attack. CHADS2-score is used to estimate stroke risk in patients with NVAF. * Or LVEF <40%. † For Xantus patients, figure related to only age >75 years old. ‡ For Xantus patients, this also could have included prior systemic embolism. ‖ 34.4% of patients had unknown CrCl values. ¶ Moderate to severe renal impairment was defined as CrCl <50 ml/min in Xantus. ** Xarelto is only approved for stroke prevention in NVAF patients with one or more risk factors.

 

  • Xarelto is evidenced across the full CHADS2-scores risk spectrum.
    XANTUS real world evidence reflects the patients seen frequently in general practice.

 

PP-XAR-ALL-1818-1

    • 1
      Camm J, et al. Eur Heart J. 2016;37:1145–1153.
    • 2
      Patel MR, et al. N Engl J Med. 2011;365:883–891.
    • a
      Atrial fibrillation (= AF). A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot… 
    • b
      Left ventricular ejection fraction (= LVEF). The measurement of how much blood is being pumped out of the left ventricle of the heart.
    • c
      Non-valvular atrial fibrillation (= NVAF). The term NVAF is restricted to cases in which atrial fibrillation occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve. 
    • d
      Transient ischaemic attack (= TIA). Also known as a ‘mini stroke’. This is caused by a temporary disruption in the blood supply to part of the brain.