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

NCT00198588 | Completed Phase 3 DMC

• 1 other identifier: ARG-HIT-CVD
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 20

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.

Conditions

Heparin-Induced Thrombocytopenia

Keywords

heparin-induced thrombocytopenia; argatroban; cardiac surgery; acute coronary syndrome; thrombosis; amputation; anticoagulation

Outcome Measures

Primary Outcomes (1)

• Death, new thrombosis, amputation

  till 37 days

Secondary Outcomes (2)

• Achievement of anticoagulation therapy

  till 37 days

• Improvement of thrombocytopenia

  till 37 days

Interventions

argatroban DRUG

beginning dose: 0.7microgram/kg/H

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health, Labour and Welfare, Japan: lead
• Tanabe Pharma Corporation: collaborator

Study Sites (20)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, 4600001, Japan

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 4668560, Japan

Location

Nagoya Daini Red Cross Hospital

Nagoya, Aichi-ken, 4668650, Japan

Location

National Hospital Organization Hakodate National Hospital

Hakodate, Hokkaido, 0418512, Japan

Location

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 0030804, Japan

Location

Kurume University Hospital

Kurume, Hukuoka, 8300011, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 6500017, Japan

Location

Kobe City General Hospital

Kobe, Hyōgo, 6500046, Japan

Location

Iwate Medical University Hospital

Morioka, Iwate, 0208505, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, 2591193, Japan

Location

Kyoto Second Red Cross Hospital

Kyoto, Kyoto, 6028026, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 6068507, Japan

Location

Mie University Hospital

Tsu, Mie-ken, 5148507, Japan

Location

National Cardiovascular Center

Suita, Osaka, 5658565, Japan

Location

Sakakibara Memorial Hospital

Fuchū, Tokyo, 1830003, Japan

Location

The University of Tokyo Hospital

Tokyo, Tokyo, 1138655, Japan

Location

National Hospital Organization Tokyo Medical Center

Tokyo, Tokyo, 1528902, Japan

Location

Keio University Hospital

Tokyo, Tokyo, 1608582, Japan

Location

National Hospital Organization Iwakuni Clinical Center

Iwakuni, Yamaguchi, 7408510, Japan

Location

Yamaguchi University Hospital

Ube, Yamaguchi, 7558505, Japan

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Thrombosis

Interventions

argatroban

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis

Study Officials

• Hitonobu TOMOIKE, MD, PhD

  National Cerebral and Cardiovascular Center, Japan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: September 1, 2006
• Last Updated: November 13, 2008

Record last verified: 2008-11

Locations

JP (20)