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

NCT00787332 | Terminated Phase 4 Results

• 1 other identifier: DES-08-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 24

Brief Summary

Compare Clinical Success and Costs in two Arms

Conditions

Suspected Heparin-Induced Thrombocytopenia

Keywords

Suspected Heparin Induced Thrombocytopenia (HIT)

Outcome Measures

Primary Outcomes (1)

• New Thrombosis, Amputation, Death, Major and Minor Bleeding

  30 days

Study Arms (2)

Desirudin

EXPERIMENTAL

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

Drug: Desirudin or Argatroban®

Argatroban®

ACTIVE COMPARATOR

Patients randomized to IV Argatroban®

Drug: Desirudin or Argatroban®

Interventions

Desirudin or Argatroban® DRUG

Desirudin 15mg SC Argatroban® IV dosing per Package Insert

Argatroban®; Desirudin

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canyon Pharmaceuticals, Inc.: lead

Study Sites (24)

University of Colorado Health Science Center

Aurora, Colorado, 80045, United States

Location

Washington Regional Cardiac Surgery

Washington D.C., District of Columbia, 20010, United States

Location

Florida Hospital Cardiovascular Research

Orlando, Florida, 32801, United States

Location

University of South Florida, Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University, Emory Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

Kaiser Permanente Medical Center

Honolulu, Hawaii, 96819, United States

Location

Provena St. Joseph's Medical Center

Joliet, Illinois, 60435, United States

Location

Mercy Medical Center

Sioux City, Iowa, 51101, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

St Mary's Hospital Rochester, Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

UMDNJ-Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

St Vincent's Hosptial -Manhattan

Manhattan, New York, 10011, United States

Location

Mount Sinai Clinical & Translational Research Institute

New York, New York, 10029, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Montefiore Medical Center, Moses Division

The Bronx, New York, 10467, United States

Location

Forsyth Regional Medical Center

Winston-Salem, North Carolina, 55902, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Cardiothoracic Vascular Surgial Specialists

Columbus, Ohio, 42314, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

Related Publications (2)

• 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.

  PMID: 21079512 DERIVED

• 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.

  PMID: 20435232 DERIVED

MeSH Terms

Interventions

desirudin; argatroban

Limitations and Caveats

Study stopped early due to poor enrollment.

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Canyon Pharmaceuticals

info@canyonpharma.com

888-434-7003

Study Officials

• Dawn Bell, PharmD

  Canyon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 10, 2013
• Results First Posted: December 31, 2012

Record last verified: 2013-01

Locations

US (24)