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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00787332
Recruitment Status : Terminated (Low enrollment)
First Posted : November 7, 2008
Results First Posted : December 31, 2012
Last Update Posted : January 10, 2013
Information provided by (Responsible Party):
Canyon Pharmaceuticals, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Suspected Heparin-Induced Thrombocytopenia
Intervention: Drug: Desirudin or Argatroban®

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled between November 2008 and December 2009 from approximately 20 US Medical Centers

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded if they had severe renal failure (CrCL<30 mL/min), known allergy to r-hirudins or argatroban, multisystem organ failure, uncontrolled bleeding.

Reporting Groups
Desirudin Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
Argatroban® Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio

Participant Flow:   Overall Study
    Desirudin   Argatroban®
STARTED   8   8 
COMPLETED   8   8 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Desirudin Patients with suspected HIT randomized to SC Desirudin i
Argatroban® Patients with suspected HIT randomized to IV Argatroban®
Total Total of all reporting groups

Baseline Measures
   Desirudin   Argatroban®   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   8   16 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   6   6   12 
>=65 years   2   2   4 
[Units: Years]
Mean (Standard Deviation)
 69  (9.5)   62  (9.3)   65  (9) 
[Units: Participants]
Female   3   3   6 
Male   5   5   10 
Region of Enrollment 
[Units: Participants]
United States   8   8   16 

  Outcome Measures

1.  Primary:   New Thrombosis, Amputation, Death, Major and Minor Bleeding   [ Time Frame: 30 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study stopped early due to poor enrollment.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Director of Clinical Trials
Organization: Canyon Pharmaceuticals
phone: 888-434-7003

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Canyon Pharmaceuticals, Inc. Identifier: NCT00787332     History of Changes
Other Study ID Numbers: DES-08-01
First Submitted: November 6, 2008
First Posted: November 7, 2008
Results First Submitted: November 29, 2012
Results First Posted: December 31, 2012
Last Update Posted: January 10, 2013