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

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Canyon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00787332
First received: November 6, 2008
Last updated: January 6, 2013
Last verified: January 2013
  Purpose

Compare Clinical Success and Costs in two Arms


Condition Intervention Phase
Suspected Heparin-Induced Thrombocytopenia
Drug: Desirudin or Argatroban®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Canyon Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • New Thrombosis, Amputation, Death, Major and Minor Bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Demonstrate clinical and economic utility between the study Arms.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787332

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

No publications provided by Canyon Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Canyon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00787332     History of Changes
Other Study ID Numbers: DES-08-01
Study First Received: November 6, 2008
Results First Received: November 29, 2012
Last Updated: January 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Canyon Pharmaceuticals, Inc.:
Suspected Heparin Induced Thrombocytopenia (HIT)

Additional relevant MeSH terms:
Thrombocytopenia
Thrombosis
Blood Platelet Disorders
Hematologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Argatroban
Desirudin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 16, 2014