Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia
Status:
Completed
Trial end date:
2006-09-01
Target enrollment:
Participant gender:
Summary
The purpose of the study is to evaluate efficacy and safety of argatroban in the patients
with heparin-induced thrombocytopenia (HIT)/ HIT and thrombosis syndrome (HITTS). This
multi-center trial covers mainly the patients with cardiovascular diseases. Subjects are
included in the trial when they are clinically diagnosed of HIT/HITTS. Initial dose of
argatroban is 0.7μg/kg/min, which is about one-third of the approved dose in the US. The
reason of the lower initial dose is that the approved dose of argatroban in Japan (for the
treatment of ischemic stroke) is about 0.7μg/kg/min and safety of higher doses of the drug
are not confirmed. A sub-study of pharmacokinetics is simultaneously conducted to reveal the
relationship among the dose, aPTT, and blood drug concentration.