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

Information source: Canyon Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Suspected Heparin-Induced Thrombocytopenia

Intervention: Desirudin or Argatroban® (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Canyon Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Dawn Bell, PharmD, Study Director, Affiliation: Canyon Pharmaceuticals, Inc.

Summary

Compare Clinical Success and Costs in two Arms

Clinical Details

Official title: A Comparative Clinical and Pharmacoeconomic Study Comparing Argatroban® IV vs Desirudin SC for Patients With Suspected Heparin-Induced Thrombocytopenia (HIT)With or Without Thrombosis Syndrome (HIT/TS)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: New Thrombosis, Amputation, Death, Major and Minor Bleeding

Detailed description: Demonstrate clinical and economic utility between the study Arms.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University of Colorado Health Science Center, Aurora, Colorado 80045, United States

Washington Regional Cardiac Surgery, Washington, DC, District of Columbia 20010, United States

Florida Hospital Cardiovascular Research, Orlando, Florida 32801, United States

University of South Florida, Tampa General Hospital, Tampa, Florida 33606, United States

Emory University, Emory Crawford Long Hospital, Atlanta, Georgia 30308, United States

Kaiser Permanente Medical Center, Honolulu, Hawaii 96819, United States

Provena St. Joseph's Medical Center, Joliet, Illinois 60435, United States

Mercy Medical Center, Sioux City, Iowa 51101, United States

Maine Medical Center, Portland, Maine 04102, United States

William Beaumont Hospital, Royal Oak, Michigan 48073, United States

St Mary's Hospital Rochester, Mayo Clinic, Rochester, Minnesota 55902, United States

UMDNJ-Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States

Montefiore Medical Center, Moses Division, Bronx, New York 10467, United States

North Shore University Hospital, Manhasset, New York 11030, United States

St Vincent's Hosptial -Manhattan, Manhattan, New York 10011, United States

Mount Sinai Clinical & Translational Research Institute, New York, New York 10029, United States

University of Rochester Medical Center, Rochester, New York 14642, United States

Forsyth Regional Medical Center, Winston-Salem, North Carolina 55902, United States

The Cleveland Clinic, Cleveland, Ohio 44195, United States

Cardiothoracic Vascular Surgial Specialists, Columbus, Ohio 42314, United States

The Ohio State University Medical Center, Columbus, Ohio 43210, United States

Methodist Hospital, Houston, Texas 77030, United States

University of Utah Hospital, Salt Lake City, Utah 84132, United States

Charleston Area Medical Center, Charleston, West Virginia 25304, United States

Additional Information

Starting date: September 2008
Last updated: January 6, 2013

Page last updated: August 20, 2015

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