Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis

NCT00913133 | Completed Phase 4 Results DMC

• 1 other identifier: DES-09-02
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 16

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.

Conditions

Thrombosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Major Bleeding

  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.

  24 hours after last dose of study drug

Secondary Outcomes (1)

• Thrombosis

  Up until 24 hours after last dose of study drug

Study Arms (1)

Desirudin

EXPERIMENTAL

desirudin 15 mg twice daily for a minimum of 5 days

Drug: Desirudin

Interventions

Desirudin DRUG

Desirudin SC 15mg q12h

Also known as: Iprivask

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 before initiation of any study related procedures.
• Be at least 18 years of age.
• Patients requiring anticoagulation for the prophylaxis of thrombosis.
• In the opinion of the Investigator, an alternative to heparin-based anticoagulant therapies is desirable.

You may not qualify if:

• Confirmed pregnancy (if woman of child-bearing potential) (urine or serum pregnancy test).
• Intracranial neoplasm, arteriovenous malformation or aneurysm.
• 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.
• Known allergy to desirudin or hirudin-derived drugs, or known sensitivity to any component of the product
• 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).
• Refusal to undergo blood transfusion should it become necessary
• Active bleeding or irreversible coagulation abnormality.
• Uncontrolled hypertension defined as a blood pressure \> or equal to 180/110 mmHg.
• Patients requiring anticoagulation for left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration or ECMO.
• 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 (16)

University of Colorado Health Science Center

Aurora, Colorado, 80045, United States

Location

University of South Florida, Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Saint Joseph's Research Institute

Atlanta, Georgia, 30342, United States

Location

Southeastern Center for Clinical Trials

Decatur, Georgia, 30033, United States

Location

Provena St. Joseph's Medical Center

Joliet, Illinois, 60435, United States

Location

Illinois Lung and Critical Care Institute

Peoria, Illinois, 61606, United States

Location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Overlook Hospital

Summit, New Jersey, 07901, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Stony Brook University Medical Center

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

Location

Forsyth Regional Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Forsyth Regional Medical Center

Winston-Salem, North Carolina, 55902, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102-1192, United States

Location

Research Concepts, Memorial Hermann Healthcare System

Houston, Texas, 77024, United States

Location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Thrombosis

Interventions

desirudin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

This was a multi-center, single-arm, observational safety trial. The lack of an active comparator does not allow us to make conclusions about the relative safety and efficacy of the product.

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

• Jerrold Levy, MD, FAHA

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2009
• First Posted: June 4, 2009
• Study Start: March 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 10, 2013
• Results First Posted: January 3, 2013

Record last verified: 2013-01

Locations

US (16)