Heparin-Induced ThrombocytopeniaPhase 3NCT00198588
Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia
A Phase 3 study testing argatroban in people with Heparin-Induced Thrombocytopenia, run by Ministry of Health, Labour and Welfare, Japan at 20 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Heparin-Induced Thrombocytopenia
- What is being tested?
- argatroban
- How many people
- 8 participants
- Where
- 20 sitesJapan
- Study dates
- Jun 2005to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Sakakibara Memorial Hospital
Fuchū, Tokyo, 1830003
National Hospital Organization Hakodate National Hospital
Hakodate, Hokkaido, 0418512
Tokai University Hospital
Isehara, Kanagawa, 2591193
National Hospital Organization Iwakuni Clinical Center
Iwakuni, Yamaguchi, 7408510
Kobe University Hospital
Kobe, Hyōgo, 6500017
Kobe City General Hospital
Kobe, Hyōgo, 6500046
Kurume University Hospital
Kurume, Hukuoka, 8300011
Kyoto Second Red Cross Hospital
Kyoto, Kyoto, 6028026
Kyoto University Hospital
Kyoto, Kyoto, 6068507
Iwate Medical University Hospital
Morioka, Iwate, 0208505
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 4600001
Nagoya University Hospital
Nagoya, Aichi-ken, 4668560
Nagoya Daini Red Cross Hospital
Nagoya, Aichi-ken, 4668650
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 0030804
National Cardiovascular Center
Suita, Osaka, 5658565
The University of Tokyo Hospital
Tokyo, Tokyo, 1138655
National Hospital Organization Tokyo Medical Center
Tokyo, Tokyo, 1528902
Keio University Hospital
Tokyo, Tokyo, 1608582
Mie University Hospital
Tsu, Mie-ken, 5148507
Yamaguchi University Hospital
Ube, Yamaguchi, 7558505
About this study
Official title: Open-Label Trial to Evaluate the Efficacy and Safety of the Use of Argatroban in Patients With Heparin-Induced Thrombocytopenia
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.
- Conditions
- Heparin-Induced Thrombocytopenia
- Being tested
- argatroban
- Keywords
- heparin-induced thrombocytopenia, argatroban, cardiac surgery, acute coronary syndrome, thrombosis, amputation, anticoagulation
- Medical subject headings
- Acute Coronary Syndrome, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
argatrobanDrug
beginning dose: 0.7microgram/kg/H
What is being measured
The primary outcome is the main question the study is designed to answer.
Death, new thrombosis, amputation
Measured: till 37 days
Secondary outcomes (2)
Achievement of anticoagulation therapy
Measured: till 37 days
Improvement of thrombocytopenia
Measured: till 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJul 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heparin-Induced ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Labour and Welfare, Japan
- Sponsor type
- Other government
- Collaborators
- Tanabe Pharma Corporation
- Investigators
- Hitonobu TOMOIKE, MD, PhD, Study chair, National Cerebral and Cardiovascular Center, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198588
- Sponsor's protocol ID
- ARG-HIT-CVD
- Status last verified
- Nov 2008
- First submitted
- 12 Sep 2005
- Last updated
- 13 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Trial to Evaluate the Efficacy and Safety of the Use of Argatroban in Patients With Heparin-Induced Thrombocytopenia
- ClinicalTrials.gov ID
- NCT00198588
- Acronym / sponsor ID
- ARG-HIT-CVD
- Conditions
- Heparin-Induced Thrombocytopenia
- Keywords
- heparin-induced thrombocytopenia, argatroban, cardiac surgery, acute coronary syndrome, thrombosis, amputation, anticoagulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ministry of Health, Labour and Welfare, JapanOther government
- Collaborators
- Tanabe Pharma Corporation
- Study start
- Jun 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- patients willing and able to give informed consent
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| argatrobanbeginning dose: 0.7microgram/kg/H | Drug | – |
Primary outcome
Death, new thrombosis, amputation
Time frame: till 37 days
2 secondary outcomes
Achievement of anticoagulation therapy
Time frame: till 37 days
Improvement of thrombocytopenia
Time frame: till 37 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2008.
Related trials for Heparin-Induced Thrombocytopenia
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Cangrelor As Treatment for Cardiac Surgery Associated With Heparin Induced Thrombocytopenia
Heparin-induced Thrombocytopenia
Recruiting
Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia
Heparin-induced Thrombocytopenia, HIT
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hitonobu TOMOIKE, MD, PhD study chair
National Cerebral and Cardiovascular Center, Japan
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing argatroban in people with Heparin-Induced Thrombocytopenia, run by Ministry of Health, Labour and Welfare, Japan at 20 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death, new thrombosis, amputation (time frame: till 37 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2008.