Justificación y diseño del estudio PREVENT-HIT: un estudio piloto aleatorizado y abierto para comparar desirudina y argatrobán en pacientes con sospecha de trombocitopenia inducida por heparina con o sin trombosis

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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PREVENT-HIT, estudio piloto aleatorizado y abierto, compara desirudina y argatrobán en pacientes con sospecha de TIH, con o sin trombosis. Se planeó incluir unos 120 pacientes en 20–25 centros estadounidenses, aleatorizados 1:1 a desirudina subcutánea (15 o 30 mg cada 12 h) o argatrobán intravenoso. Criterio principal, hasta 30 días tras suspender el fármaco: trombosis nueva o agravada que exigiera suspenderlo, amputación o mortalidad por cualquier causa. Por la lenta inclusión se reclutaron 16 pacientes; los resultados se publicarán aparte.

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