A Comparative Sudy Comparing Argatroban® IV vs Desirudin SC for Suspected HIT With or Without Thrombosis Syndrome (HIT)

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)

Compare Clinical Success and Costs in two Arms

Study Overview

• Status: Terminated
• Conditions: Suspected Heparin-Induced Thrombocytopenia
• Intervention / Treatment: Drug: Desirudin or Argatroban®

Detailed Description

Demonstrate clinical and economic utility between the study Arms.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health Science Center
  • District of Columbia
    • Washington, DC, District of Columbia, United States, 20010
      • Washington Regional Cardiac Surgery
  • Florida
    • Orlando, Florida, United States, 32801
      • Florida Hospital Cardiovascular Research
    • Tampa, Florida, United States, 33606
      • University of South Florida, Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University, Emory Crawford Long Hospital
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Permanente Medical Center
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Provena St. Joseph's Medical Center
  • Iowa
    • Sioux City, Iowa, United States, 51101
      • Mercy Medical Center
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • St Mary's Hospital Rochester, Mayo Clinic
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • UMDNJ-Robert Wood Johnson Medical School
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center, Moses Division
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • Manhattan, New York, United States, 10011
      • St Vincent's Hosptial -Manhattan
    • New York, New York, United States, 10029
      • Mount Sinai Clinical & Translational Research Institute
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 55902
      • Forsyth Regional Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center
    • Columbus, Ohio, United States, 42314
      • Cardiothoracic Vascular Surgial Specialists
  • Texas
    • Houston, Texas, United States, 77030
      • Methodist Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Desirudin; Patients with suspected HIT without thrombosis syndrome (HIT/TS), randomized to SC Desirudin	Drug: Desirudin or Argatroban®; Desirudin 15mg SC Argatroban® IV dosing per Package Insert
ACTIVE_COMPARATOR: Argatroban®; Patients randomized to IV Argatroban®	Drug: Desirudin or Argatroban®; Desirudin 15mg SC Argatroban® IV dosing per Package Insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
New Thrombosis, Amputation, Death, Major and Minor Bleeding	30 days

Collaborators and Investigators

• Sponsor: Canyon Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: November 6, 2008
• First Submitted That Met QC Criteria: November 6, 2008
• First Posted (ESTIMATE): November 7, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2013
• Last Update Submitted That Met QC Criteria: January 6, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Suspected Heparin Induced Thrombocytopenia (HIT)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Embolism and Thrombosis; Blood Platelet Disorders; Thrombosis; Thrombocytopenia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Argatroban; Desirudin
• Other Study ID Numbers: DES-08-01