Clinical trial NCT00787332: A Comparative Sudy Comparing Argatroban® IV vs Desirudin SC for Suspected HIT With or Without Thrombosis Syndrome
Official title: A Comparative Clinical and Pharmacoeconomic Study Comparing Argatroban® IV vs Desirudin SC for Patients With Suspected Heparin-Induced Thrombocytopenia (HIT)With or Without Thrombosis Syndrome (HIT/TS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Suspected Heparin-Induced Thrombocytopenia
Keywords: Suspected Heparin Induced Thrombocytopenia (HIT)
Lead sponsor: Canyon Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Compare Clinical Success and Costs in two Arms

Detailed description: Demonstrate clinical and economic utility between the study Arms.

Eligibility criteria: Inclusion Criteria:

1. Provide written Informed Consent
2. Be at least 18 years of age.
3. A suspicion of heparin-induced thrombocytopenia with or without thrombosis syndrome (HIT/TS) due to one of the following clinical scenarios:

   1. Patients who are receiving heparin/LMWH or have received heparin/LMWH within the previous 100 days AND one of the following:

      * have a fall in platelet count of \> 30% from a baseline prior to heparin/LMWH, OR
      * have a thrombotic event, OR
      * develop skin lesions secondary to subcutaneous heparin (even if the patient is no longer receiving heparin therapy when thrombocytopenia, thrombosis or skin lesions occur).

      Patients with thrombosis or skin lesions need not have concomitant thrombocytopenia to be included.
   2. A rapid fall in the platelet count by \>30% from baseline within 24 hours after starting heparin/LMWH in patients with suspected exposure to heparin or LMWH in the previous 100 days (e.g. hospitalization or invasive procedure within the past 100 days).
   3. In post-operative cardiac surgery patients, development of thrombocytopenia defined as a decrease in platelet count by \>30% from the post-operative peak; or patients whose platelet count fails to increase post-operatively (e.g. remains \< 100,000 mm3 at Day 4 or later, calendar day of surgery=Day 0).
4. In patients with the diagnosis of HIT/TS established by a hematology consultant, but in whom the above criteria are not fulfilled, the Investigator should contact the Medical Monitor for consideration of the patient's inclusion in this study (A hematology consult is highly advisable, but not required prior to randomization).

Exclusion Criteria:

* Confirmed pregnancy (if woman of child-bearing potential- urine or serum pregnancy test).
* Patients with suspected or confirmed pulmonary embolism, requiring continued anticoagulation or acute ischemic stroke will be excluded
* Cerebrovascular accident within the previous 6 months
* Intracranial neoplasm, arteriovenous malformation or aneurysm.
* Severe renal insufficiency as determined by measured or estimated creatinine clearance \< 30 ml/min.
* Known allergy to Argatroban®, Desirudin or hirudin derived drugs, or known sensitivity to any component of the product
* Patients receiving recombinant hirudin (e.g. lepirudin) within the previous 6 months prior to enrollment.
* Patients receiving \>2 doses of fondaparinux for treatment of suspected HIT
* Multi-system organ failure or estimated survival of less than 30 days.
* Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
* Refusal to undergo blood transfusion should it become necessary
* Active bleeding or irreversible coagulation abnormality
* Uncontrolled hypertension defined as a blood pressure \>180/110 mm Hg.
* Patients requiring indwelling mechanical intervention such as left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration, etc.
* Severe liver disease and any other disease or condition, which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.

Primary outcomes:
measure: New Thrombosis, Amputation, Death, Major and Minor Bleeding
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Health Science Center
state: Colorado
city: Washington, DC
country: United States
facility: Washington Regional Cardiac Surgery
state: District of Columbia
city: Orlando
country: United States
facility: Florida Hospital Cardiovascular Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University, Emory Crawford Long Hospital
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Medical Center
state: Hawaii
city: Joliet
country: United States
facility: Provena St. Joseph's Medical Center
state: Illinois
city: Sioux City
country: United States
facility: Mercy Medical Center
state: Iowa
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Rochester
country: United States
facility: St Mary's Hospital Rochester, Mayo Clinic
state: Minnesota
city: New Brunswick
country: United States
facility: UMDNJ-Robert Wood Johnson Medical School
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center, Moses Division
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Manhattan
country: United States
facility: St Vincent's Hosptial -Manhattan
state: New York
city: New York
country: United States
facility: Mount Sinai Clinical & Translational Research Institute
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Forsyth Regional Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Cardiothoracic Vascular Surgial Specialists
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
Study officials:
affiliation: Canyon Pharmaceuticals, Inc.
name: Dawn Bell, PharmD
role: STUDY_DIRECTOR
References:
citation: Boyce SW, Bandyk DF, Bartholomew JR, Frame JN, Rice L. A randomized, open-label pilot study comparing desirudin and argatroban in patients with suspected heparin-induced thrombocytopenia with or without thrombosis: PREVENT-HIT Study. Am J Ther. 2011 Jan;18(1):14-22. doi: 10.1097/MJT.0b013e3181f65503.
citation: Frame JN, Rice L, Bartholomew JR, Whelton A. Rationale and design of the PREVENT-HIT study: a randomized, open-label pilot study to compare desirudin and argatroban in patients with suspected heparin-induced thrombocytopenia with or without thrombosis. Clin Ther. 2010 Apr;32(4):626-36. doi: 10.1016/j.clinthera.2010.04.012.