| 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. | |
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MedLine Citation:
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PMID: 20435232 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Desirudin, a bivalent direct thrombin inhibitor (DTI), is approved by the US Food and Drug Administration for the prevention of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing elective hip replacement surgery. It became available in the United States in March 2010. OBJECTIVE: The goal of the present article was to provide an overview of the rationale and design of the PREVENT-HIT study, a randomized, prospective, open-label, active drug-controlled, exploratory trial comparing the clinical and economic utility of desirudin versus argatroban in patients with suspected heparin-induced thrombocytopenia (HIT), with or without thrombosis. SUMMARY: The PREVENT-HIT study was designed to enroll approximately 120 patients from 20 to 25 US centers. All eligible patients were required to be aged >or=18 years. Patients with suspected HIT with or without thrombosis were divided into 2 treatment arms and randomized to receive treatment with desirudin or argatroban in a 1:1 ratio using a block randomization method. Arm A comprised patients who were naive to DTI therapy; arm B included patients whose condition was previously stabilized with intravenous argatroban. Desirudin was administered as a fixed-dose injection (15 or 30 mg SC q12h in patients without or with thrombosis, respectively). Argatroban was administered by continuous intravenous infusion in accordance with approved prescribing information or institutional prescribing guidelines at each study site. The primary efficacy outcome measure included the occurrence of any of the following up to 30 days after study drug discontinuation: new-onset or worsening thrombosis requiring discontinuation of study drug; amputation; or all-cause mortality. Other outcomes that were assessed included platelet recovery, bleeding, and pharmacoeconomic parameters. In addition, adverse events and other safety parameters were evaluated. Study enrollment began in November 2008 and ended in December 2009 due to slow enrollment (N = 16). The study results will be published separately. CONCLUSION: The results from the PREVENT-HIT study should enhance understanding of the comparative clinical and economic utility of desirudin and argatroban in patients with HIT with or without thrombosis. ClinicalTrials.gov identifier: NCT00787332. |
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Authors:
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James N Frame; Lawrence Rice; John R Bartholomew; Andrew Whelton |
Publication Detail:
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Type: Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Clinical therapeutics Volume: 32 ISSN: 1879-114X ISO Abbreviation: Clin Ther Publication Date: 2010 Apr |
Date Detail:
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Created Date: 2010-05-03 Completed Date: 2010-07-26 Revised Date: 2010-09-09 |
Medline Journal Info:
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Nlm Unique ID: 7706726 Medline TA: Clin Ther Country: United States |
Other Details:
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Languages: eng Pagination: 626-36 Citation Subset: IM |
Affiliation:
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David Lee Outpatient Cancer Center, Charleston Area Medical Center, West Virginia University School of Medicine-Charleston Division, Charleston, West Virginia, USA. james.frame@camc.org |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00787332 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Anticoagulants
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adverse effects,
therapeutic use* Female Heparin / adverse effects* Hirudins / adverse effects Humans Male Pilot Projects Pipecolic Acids / adverse effects, therapeutic use* Prospective Studies Recombinant Proteins / adverse effects, therapeutic use Research Design Thrombocytopenia / chemically induced*, complications, drug therapy* Thrombosis / complications* |
| Chemical | |
Reg. No./Substance:
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0/Anticoagulants; 0/Hirudins; 0/Pipecolic Acids; 0/Recombinant Proteins; 120993-53-5/desirudin; 74863-84-6/argatroban; 9005-49-6/Heparin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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