Argatroban and alteplase in patients with acute myocardial infarction: TheARGAMI study

ARGAMI was designed to assess safety and efficacy of argatroban compared wi th heparin as adjunctive treatment to alteplase in the treatment of patient s with acute myocardial infarction. ARGAMI consisted of an open-dose findin g study (35 patients) followed by a placebo-controlled study with double du mmy technique and 2:1 (argatroban:heparin) randomization. An argatroban dos age of 100 mug/kg bolus plus 3 mug/kg/min infusion for 72 hours was selecte d for the randomized study in which 82 patients were allocated to argatroba n and 45 to heparin (5000 U intravenous bolus, 1000 U/h infusion). Patency of the infarct-related artery (Thrombolysis in Myocardial Infarction [TIMI] grade 2 or 3 flow) after 90 minutes was obtained in 62 patients (76%) allo cated to argatroban versus 37 patients (82%) allocated to heparin (p = ns). Angiograms after 24 hours and 5 to 10 days showed low reocclusion rates in both groups. Bleeding complications were observed in 16 patients allocated to argatroban (19.5%) and in 9 patients allocated to heparin (20.0%). One patient allocated to heparin suffered from hemorrhage stroke. Argatroban, g iven as adjunctive treatment to alteplase, is tolerated well in patients wi th acute myocardial infarction. Safety and efficacy of the combination alte plase and argatroban (with this dose regimen) are similar to those of altep lase and heparin.