Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia
This study has been completed.
Sponsor:
Ministry of Health, Labour and Welfare, Japan
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by:
Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier:
NCT00198588
First received: September 12, 2005
Last updated: November 11, 2008
Last verified: November 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heparin-Induced Thrombocytopenia |
Drug: argatroban |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-Label Trial to Evaluate the Efficacy and Safety of the Use of Argatroban in Patients With Heparin-Induced Thrombocytopenia |
Resource links provided by NLM:
Further study details as provided by Ministry of Health, Labour and Welfare, Japan:
Primary Outcome Measures:
- Death, new thrombosis, amputation [ Time Frame: till 37 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Achievement of anticoagulation therapy [ Time Frame: till 37 days ] [ Designated as safety issue: Yes ]
- Improvement of thrombocytopenia [ Time Frame: till 37 days ] [ Designated as safety issue: No ]
| Enrollment: | 8 |
| Study Start Date: | June 2005 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: argatroban
beginning dose: 0.7microgram/kg/H
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198588
Locations
| Japan | |
| National Hospital Organization Nagoya Medical Center | |
| Nagoya, Aichi, Japan, 4600001 | |
| Nagoya University Hospital | |
| Nagoya, Aichi, Japan, 4668560 | |
| Nagoya Daini Red Cross Hospital | |
| Nagoya, Aichi, Japan, 4668650 | |
| National Hospital Organization Hakodate National Hospital | |
| Hakodate, Hokkaido, Japan, 0418512 | |
| National Hospital Organization Hokkaido Cancer Center | |
| Sapporo, Hokkaido, Japan, 0030804 | |
| Kurume University Hospital | |
| Kurume, Hukuoka, Japan, 8300011 | |
| Kobe City General Hospital | |
| Kobe, Hyogo, Japan, 6500046 | |
| Kobe University Hospital | |
| Kobe, Hyogo, Japan, 6500017 | |
| Iwate Medical University Hospital | |
| Morioka, Iwate, Japan, 0208505 | |
| Tokai University Hospital | |
| Isehara, Kanagawa, Japan, 2591193 | |
| Mie University Hospital | |
| Tsu, Mie, Japan, 5148507 | |
| National Cardiovascular Center | |
| Suita, Osaka, Japan, 5658565 | |
| Sakakibara Memorial Hospital | |
| Fuchu, Tokyo, Japan, 1830003 | |
| National Hospital Organization Iwakuni Clinical Center | |
| Iwakuni, Yamaguchi, Japan, 7408510 | |
| Yamaguchi University Hospital | |
| Ube, Yamaguchi, Japan, 7558505 | |
| Kyoto University Hospital | |
| Kyoto, Japan, 6068507 | |
| Kyoto Second Red Cross Hospital | |
| Kyoto, Japan, 6028026 | |
| National Hospital Organization Tokyo Medical Center | |
| Tokyo, Japan, 1528902 | |
| The University of Tokyo Hospital | |
| Tokyo, Japan, 1138655 | |
| Keio University Hospital | |
| Tokyo, Japan, 1608582 | |
Sponsors and Collaborators
Ministry of Health, Labour and Welfare, Japan
Mitsubishi Tanabe Pharma Corporation
Investigators
| Study Chair: | Hitonobu TOMOIKE, MD, PhD | National Cerebral and Cardiovascular Center |
More Information
No publications provided
| Responsible Party: | Haruko Yamamoto, National Cardiovascular Center |
| ClinicalTrials.gov Identifier: | NCT00198588 History of Changes |
| Other Study ID Numbers: | ARG-HIT-CVD |
| Study First Received: | September 12, 2005 |
| Last Updated: | November 11, 2008 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Ministry of Health, Labour and Welfare, Japan:
|
heparin-induced thrombocytopenia argatroban cardiac surgery acute coronary syndrome |
thrombosis amputation anticoagulation |
Additional relevant MeSH terms:
|
Thrombocytopenia Blood Platelet Disorders Hematologic Diseases Argatroban Heparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Platelet Aggregation Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013