Clinical Trial: Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open-Label Trial to Evaluate the Efficacy and Safety of the Use of Argatroban in Patients With Heparin-Induced Thrombocytopenia

Brief 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.

Detailed Summary:
Sponsor: Ministry of Health, Labour and Welfare, Japan

Current Primary Outcome: Death, new thrombosis, amputation [ Time Frame: till 37 days ]

Original Primary Outcome: the incidence of thrombosis, amputation and death

Current Secondary Outcome:

  • Achievement of anticoagulation therapy [ Time Frame: till 37 days ]
  • Improvement of thrombocytopenia [ Time Frame: till 37 days ]


Original Secondary Outcome:

  • the incidence of all death
  • the incidence of new thrombosis
  • the incidence of amputation
  • the incidence of death from thrombosis
  • acievement of anticoagulation therapy
  • Improvement of thrombocytopenia


Information By: Ministry of Health, Labour and Welfare, Japan

Dates:
Date Received: September 12, 2005
Date Started: June 2005
Date Completion:
Last Updated: November 11, 2008
Last Verified: November 2008