Status:
COMPLETED
Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia
Lead Sponsor:
Ministry of Health, Labour and Welfare, Japan
Collaborating Sponsors:
Tanabe Pharma Corporation
Conditions:
Heparin-Induced Thrombocytopenia
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
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 cove...
Eligibility Criteria
Inclusion
- Males of non-pregnant females \>=20 and \<=80 years of age
- Those with the diagnosis of HIT or HITTS made by the following diagnostic criteria, or those who have positive results of HIT antibody
- diagnostic criteria of HIT
- a fall in platelet count to less than 100,000/μL or a 50% decrease in platelets after the initiation of heparin therapy with no apparent explanation other than HIT
- diagnostic criteria of HITTS
- those who met the diagnosis criteria of HIT
- presence of an arterial or venous thrombosis documented by appropriate imaging technique (ultrasound, angiography etc.) or supported by clinical evidence such as a myocardial infarction, stroke, pulmonary embolism, or other clinical indications of vascular occlusion(absence of pulse, cold, cyanotic extremities, etc.)
- patients with history of HIT/HITTS with positive test results (HIT antibody or platelet function test) could be enrolled without present thrombocytopenia
- patients willing and able to give informed consent
Exclusion
- any condition which in the investigator's opinion, contraindicated the use of argatroban or endangered the patient if he or she participated in this trial
- clinically significant or uncontrolled endocrine, renal, pulmonary, gastrointestinal, or psychiatric disorder of sufficient severity that the investigator deemed antithrombotic therapy with argatroban to be contraindicated
- unexplained aPTT\>200% of control at baseline
- documented coagulation disorder or unexplained bleeding diathesis unrelated to HIT
- lumbar puncture within the past 7 days
- known clinical site of bleeding. Patients with a known site of clinical bleeding could be enrolled if the investigator deemed the risk of continued thrombosis outweighed the potential bleeding risk
- serious liver disfunction
- females of known or suspected pregnancy
- breast feeding females
- participation in other clinical drug trials within the past 30 days
- history of hypersensitivity to argatroban
- concomitant use of cimetidine
- previous participation in this trial
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00198588
Start Date
June 1 2005
End Date
September 1 2006
Last Update
November 13 2008
Active Locations (20)
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1
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan, 4600001
2
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 4668560
3
Nagoya Daini Red Cross Hospital
Nagoya, Aichi-ken, Japan, 4668650
4
National Hospital Organization Hakodate National Hospital
Hakodate, Hokkaido, Japan, 0418512