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

Primary Purpose

Heparin-Induced Thrombocytopenia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
argatroban
Sponsored by
Ministry of Health, Labour and Welfare, Japan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heparin-Induced Thrombocytopenia focused on measuring heparin-induced thrombocytopenia, argatroban, cardiac surgery, acute coronary syndrome, thrombosis, amputation, anticoagulation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • National Hospital Organization Nagoya Medical Center
  • Nagoya University Hospital
  • Nagoya Daini Red Cross Hospital
  • National Hospital Organization Hakodate National Hospital
  • National Hospital Organization Hokkaido Cancer Center
  • Kurume University Hospital
  • Kobe University Hospital
  • Kobe City General Hospital
  • Iwate Medical University Hospital
  • Tokai University Hospital
  • Mie University Hospital
  • National Cardiovascular Center
  • Sakakibara Memorial Hospital
  • National Hospital Organization Iwakuni Clinical Center
  • Yamaguchi University Hospital
  • Kyoto Second Red Cross Hospital
  • Kyoto University Hospital
  • The University of Tokyo Hospital
  • National Hospital Organization Tokyo Medical Center
  • Keio University Hospital

Outcomes

Primary Outcome Measures

Death, new thrombosis, amputation

Secondary Outcome Measures

Achievement of anticoagulation therapy
Improvement of thrombocytopenia

Full Information

First Posted
September 12, 2005
Last Updated
November 11, 2008
Sponsor
Ministry of Health, Labour and Welfare, Japan
Collaborators
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00198588
Brief Title
Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia
Official Title
Open-Label Trial to Evaluate the Efficacy and Safety of the Use of Argatroban in Patients With Heparin-Induced Thrombocytopenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Health, Labour and Welfare, Japan
Collaborators
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heparin-Induced Thrombocytopenia
Keywords
heparin-induced thrombocytopenia, argatroban, cardiac surgery, acute coronary syndrome, thrombosis, amputation, anticoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
argatroban
Intervention Description
beginning dose: 0.7microgram/kg/H
Primary Outcome Measure Information:
Title
Death, new thrombosis, amputation
Time Frame
till 37 days
Secondary Outcome Measure Information:
Title
Achievement of anticoagulation therapy
Time Frame
till 37 days
Title
Improvement of thrombocytopenia
Time Frame
till 37 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hitonobu TOMOIKE, MD, PhD
Organizational Affiliation
National Cerebral and Cardiovascular Center, Japan
Official's Role
Study Chair
Facility Information:
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4600001
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4668560
Country
Japan
Facility Name
Nagoya Daini Red Cross Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4668650
Country
Japan
Facility Name
National Hospital Organization Hakodate National Hospital
City
Hakodate
State/Province
Hokkaido
ZIP/Postal Code
0418512
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
0030804
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Hukuoka
ZIP/Postal Code
8300011
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
6500017
Country
Japan
Facility Name
Kobe City General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
6500046
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
0208505
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
2591193
Country
Japan
Facility Name
Mie University Hospital
City
Tsu
State/Province
Mie
ZIP/Postal Code
5148507
Country
Japan
Facility Name
National Cardiovascular Center
City
Suita
State/Province
Osaka
ZIP/Postal Code
5658565
Country
Japan
Facility Name
Sakakibara Memorial Hospital
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
1830003
Country
Japan
Facility Name
National Hospital Organization Iwakuni Clinical Center
City
Iwakuni
State/Province
Yamaguchi
ZIP/Postal Code
7408510
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
7558505
Country
Japan
Facility Name
Kyoto Second Red Cross Hospital
City
Kyoto
ZIP/Postal Code
6028026
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
6068507
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Tokyo
ZIP/Postal Code
1138655
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center
City
Tokyo
ZIP/Postal Code
1528902
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
1608582
Country
Japan

12. IPD Sharing Statement

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

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