Abstract

In an open-label pilot study of 20 patients with unstable angina (Braunwald class I–III), hirulog was administered as a continuous intravenous infusion for 5 days in a dose of 0.2 mg/kg/hour to produce an activated partial thromboplastin time of approximately 200% of control. The primary end points of the study were: death, development of a transmural myocardial infarction, and intractable angina needing interventions such as an intraaortic balloon pump insertion, angioplasty and surgery. The secondary end points were the presence of an intracoronary thrombus detected on angiography and hemorrhagic complications during therapy. There was no death or transmural infarction in this study cohort; however, 1 patient developed intractable angina. Intracoronary thrombus was documented in 2 patients. Infusion of hirulog resulted in a steady prolongation of the activated partial thromboplastin time without any hemorrhagic or other adverse effect. Hirulog appears to be an effective antithrombotic agent that is tolerated well and may have advantages over heparin in the management of patients with unstable angina.

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