The most commonly reported adverse event causally related to AGGRASTAT therapy (used concurrently with unfractionated heparin and acetylsalicylic acid) was bleeding, which was usually mild in nature.  In the PRISM-PLUS study, the overall incidence of major bleeding using the Thrombolysis In Myocardial Infarction criteria (defined as a hemoglobin drop >50 g/L with or without an identified site, intracranial hemorrhage, or cardiac tamponade) in patients treated with AGGRASTAT plus heparin was not significantly higher than in the control group (1.4% for AGGRASTAT plus heparin vs. 0.8% for the control group, which received heparin alone).  The incidence of minor bleeding using the Thrombolysis In Myocardial Infarction criteria (defined as a hemoglobin drop >30 g/L with bleeding from a known site, spontaneous gross hematuria, hematemesis, or hemoptysis) was 10.5% for AGGRASTAT plus heparin and 8.0% for the control group.  There were no reports of intracranial bleeding for either group.¹

Other common adverse reactions associated with AGGRASTAT given concurrently with heparin, apart from bleeding, were nausea (1.7%), fever (1.5%), and headache (1.1%).  Incidences of nonbleeding-related adverse events were similar for the AGGRASTAT plus heparin and the heparin alone groups.

See PRISM-PLUS page for additional information.