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

Summary

Compare Clinical Success and Costs in two Arms

Timeline

Start

2008-09

Primary completion

2009-12

Completion

2009-12

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped (Enrollment): “Low enrollment”

paper The study results will be published separately. PMID 20435232 ↗

Publications

• Boyce SW, Bandyk DF, Bartholomew JR, Frame JN, Rice L. A randomized, open-label pilot study comparing desirudin and argatroban in patients with suspected heparin-induced thrombocytopenia with or without thrombosis: PREVENT-HIT Study. Am J Ther. 2011 Jan;18(1):14-22. doi: 10.1097/MJT.0b013e3181f65503.
• Frame JN, Rice L, Bartholomew JR, Whelton A. 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. Clin Ther. 2010 Apr;32(4):626-36. doi: 10.1016/j.clinthera.2010.04.012.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Argatroban	Small molecule	—	Intravenous
Subject	Desirudin	Protein / enzyme biologic	15 mg	Subcutaneous
Subject	Desirudin	Protein / enzyme biologic	30 mg	Subcutaneous

Indications