Anagre Cap. in Patients With High-Risk Essential Thrombocythemia

A Multicenter, Open-label, Clinical Study for Efficacy and Safety Evaluation of Anagrelide in Patients With Treatment-naïve, High-risk Essential Thrombocythemia as a Primary Treatment

This study is to evaluate the efficacy and safety according to incremental dosing for 8 weeks and duration of administration for 1 year in patients with high-risk essential thrombocythemia.

Inclusion Criteria:

• Patients with essential thrombocythemia according to WHO 2008

• Any of the following as high-risk patient

  • Over 60 years old
  • >100 X 10^4/ul of platelet count
  • increased more than 300K of platelet count in 3 months
  • Hypertension, diabetes, past history of thromboembolic bleeding

Exclusion Criteria:

• Patients with an adverse drug reaction or intolerability to anagrelide

• Any of the following cardiac abnormalities;

  • Complete left bundle branch block on ECG
  • Patients using a pacemaker
  • Patients with a family history of congenital QT prolongation syndrome or known QT prolongation syndrome
  • Currently, there is no clinically uncontrolled ventricular or atrial tachycardia
  • Clinically significant bradycardia (<less than 50 per minute)
  • History of clinically proven myocardial infarction and unstable angina within 3 months

• Pregnant women, nursing mothers