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

NCT ID: NCT00787332

Last Updated: 2013-01-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-12-31

Brief Summary

Compare Clinical Success and Costs in two Arms

Detailed Description

Demonstrate clinical and economic utility between the study Arms.

Conditions

Suspected Heparin-Induced Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Desirudin

Patients with suspected HIT without thrombosis syndrome (HIT/TS), randomized to SC Desirudin

Group Type: EXPERIMENTAL

Desirudin or Argatroban®

Intervention Type: DRUG

Desirudin 15mg SC Argatroban® IV dosing per Package Insert

Argatroban®

Patients randomized to IV Argatroban®

Group Type: ACTIVE_COMPARATOR

Desirudin or Argatroban®

Intervention Type: DRUG

Desirudin 15mg SC Argatroban® IV dosing per Package Insert

Interventions

Desirudin or Argatroban®

Desirudin 15mg SC Argatroban® IV dosing per Package Insert

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canyon Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dawn Bell, PharmD

Role: STUDY_DIRECTOR

Canyon Pharmaceuticals, Inc.

Locations

University of Colorado Health Science Center

Aurora, Colorado, United States

Washington Regional Cardiac Surgery

Washington D.C., District of Columbia, United States

Florida Hospital Cardiovascular Research

Orlando, Florida, United States

University of South Florida, Tampa General Hospital

Tampa, Florida, United States

Emory University, Emory Crawford Long Hospital

Atlanta, Georgia, United States

Kaiser Permanente Medical Center

Honolulu, Hawaii, United States

Provena St. Joseph's Medical Center

Joliet, Illinois, United States

Mercy Medical Center

Sioux City, Iowa, United States

Maine Medical Center

Portland, Maine, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

St Mary's Hospital Rochester, Mayo Clinic

Rochester, Minnesota, United States

UMDNJ-Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

North Shore University Hospital

Manhasset, New York, United States

St Vincent's Hosptial -Manhattan

Manhattan, New York, United States

Mount Sinai Clinical & Translational Research Institute

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Montefiore Medical Center, Moses Division

The Bronx, New York, United States

Forsyth Regional Medical Center

Winston-Salem, North Carolina, United States

The Cleveland Clinic

Cleveland, Ohio, United States

Cardiothoracic Vascular Surgial Specialists

Columbus, Ohio, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Methodist Hospital

Houston, Texas, United States

University of Utah Hospital

Salt Lake City, Utah, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21079512 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20435232 (View on PubMed)

Other Identifiers

DES-08-01

Identifier Type: -

Identifier Source: org_study_id