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

Phase 3
20 Years
80 Years
Not Enrolling
Heparin-Induced Thrombocytopenia

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Trial Information

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

Inclusion Criteria:

1. Males of non-pregnant females >=20 and <=80 years of age

2. 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

- 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

3. patients willing and able to give informed consent

Exclusion Criteria:

1. 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

2. 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

3. unexplained aPTT>200% of control at baseline

4. documented coagulation disorder or unexplained bleeding diathesis unrelated to HIT

5. lumbar puncture within the past 7 days

6. 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

7. serious liver disfunction

8. females of known or suspected pregnancy

9. breast feeding females

10. participation in other clinical drug trials within the past 30 days

11. history of hypersensitivity to argatroban

12. concomitant use of cimetidine

13. previous participation in this trial

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Death, new thrombosis, amputation

Outcome Time Frame:

till 37 days

Safety Issue:


Principal Investigator

Hitonobu TOMOIKE, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cerebral and Cardiovascular Center


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

June 2005

Completion Date:

September 2006

Related Keywords:

  • Heparin-Induced Thrombocytopenia
  • heparin-induced thrombocytopenia
  • argatroban
  • cardiac surgery
  • acute coronary syndrome
  • thrombosis
  • amputation
  • anticoagulation
  • Thrombocytopenia