Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis (DESIR-ABLE)

• ClinicalTrials.gov Identifier: NCT00913133
• Recruitment Status: Completed
• First Posted: June 4, 2009
• Results First Posted: January 3, 2013
• Last Update Posted: January 10, 2013
• Sponsor: Canyon Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Canyon Pharmaceuticals, Inc.

Study Description

Brief Summary:

The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.

Condition or disease	Intervention/treatment	Phase
Thrombosis	Drug: Desirudin	Phase 4

Detailed Description:

Hospitalized patients who require DVT prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 516 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multi-Center Trial of Desirudin for the Prophylaxis of Thrombosis: an Alternative to Heparin-Based Anticoagulation (DESIR-ABLE)
• Study Start Date: March 2010
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: June 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Desirudin; desirudin 15 mg twice daily for a minimum of 5 days	Drug: Desirudin; Desirudin SC 15mg q12h; Other Name: Iprivask

Outcome Measures

Primary Outcome Measures :

1. Major Bleeding [ Time Frame: 24 hours after last dose of study drug ]
   Major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the peri-operative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint.

Secondary Outcome Measures :

1. Thrombosis [ Time Frame: Up until 24 hours after last dose of study drug ]
   • New onset symptomatic thrombosis requiring medical or surgical intervention;
   • Death due to thrombosis defined as fatal pulmonary embolism, ischemic stroke, mesenteric thrombosis or myocardial infarction.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Provide written informed consent before initiation of any study related procedures.
2. Be at least 18 years of age.
3. Patients requiring anticoagulation for the prophylaxis of thrombosis.
4. In the opinion of the Investigator, an alternative to heparin-based anticoagulant therapies is desirable.

Exclusion Criteria:

1. Confirmed pregnancy (if woman of child-bearing potential) (urine or serum pregnancy test).
2. Intracranial neoplasm, arteriovenous malformation or aneurysm.
3. Severe renal insufficiency (chronic or acute) with a GFR of < or equal to 30 mL/min as determined by measured or estimated creatinine clearance using Cockroft-Gault method or by estimated GFR using the MDRD formula.
4. Known allergy to desirudin or hirudin-derived drugs, or known sensitivity to any component of the product
5. Participation in other clinical research studies involving the evaluation of other investigational or FDA-approved drugs or devices within 30 days of enrollment (participation in observational studies of FDA-approved products is acceptable).
6. Refusal to undergo blood transfusion should it become necessary
7. Active bleeding or irreversible coagulation abnormality.
8. Uncontrolled hypertension defined as a blood pressure > or equal to 180/110 mmHg.
9. Patients requiring anticoagulation for left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration or ECMO.
10. 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

Locations

United States, Colorado

University of Colorado Health Science Center

Aurora, Colorado, United States, 80045

United States, Florida

University of South Florida, Tampa General Hospital

Tampa, Florida, United States, 33606

United States, Georgia

Saint Joseph's Research Institute

Atlanta, Georgia, United States, 30342

Southeastern Center for Clinical Trials

Decatur, Georgia, United States, 30033

United States, Illinois

Provena St. Joseph's Medical Center

Joliet, Illinois, United States, 60435

Illinois Lung and Critical Care Institute

Peoria, Illinois, United States, 61606

United States, Missouri

St. John's Mercy Medical Center

St. Louis, Missouri, United States, 63141

United States, New Jersey

Overlook Hospital

Summit, New Jersey, United States, 07901

United States, New York

Weill Cornell Medical College

New York, New York, United States, 10065

Stony Brook University Medical Center

Stony Brook, New York, United States, 11794-8191

United States, North Carolina

Forsyth Regional Medical Center

Winston-Salem, North Carolina, United States, 27103

Forsyth Regional Medical Center

Winston-Salem, North Carolina, United States, 55902

United States, Ohio

The Ohio State University Medical Center

Columbus, Ohio, United States, 43210

United States, Pennsylvania

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States, 19102-1192

United States, Texas

Research Concepts, Memorial Hermann Healthcare System

Houston, Texas, United States, 77024

United States, Virginia

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States, 24014

Sponsors and Collaborators

Canyon Pharmaceuticals, Inc.

Investigators

• Study Director: Dawn Bell, PharmD; Canyon Pharmaceuticals, Inc.
• Principal Investigator: Jerrold Levy, MD, FAHA; Emory University

More Information

• Responsible Party: Canyon Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT00913133
• Other Study ID Numbers: DES-09-02
• First Posted: June 4, 2009
• Results First Posted: January 3, 2013
• Last Update Posted: January 10, 2013
• Last Verified: January 2013

Keywords provided by Canyon Pharmaceuticals, Inc.:

Anticoagulation; Prophylaxis; Desirudin; Direct thrombin inhibitor; Heparin-induced thrombocytopenia

Additional relevant MeSH terms:

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Desirudin; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action