An interim report of a double-blind placebo-controlled recanalisation study of anisoylated plasminogen streptokinase activator complex in acute myocardial infarction.

This is an interim report of the initial 36 patients entered into the first double-blind, placebo-controlled invasive arteriographic study of intravenous anisoylated plasminogen streptokinase activator complex (APSAC) for coronary recanalisation in acute myocardial infarction. Coronary arteriography was performed before and 90 minutes after a single intravenous bolus injection of APSAC or placebo given over 2 to 5 minutes. Pretreatment coronary arteriography was performed in 36 patients at a mean time of 189 +/- 75 minutes after the onset of symptoms. 28 patients had occluded infarct-related coronary arteries and were randomised to receive APSAC 30U (n = 15) or placebo (n = 13) by intravenous injection 195 +/- 72 minutes after the onset of symptoms. Coronary arteriography 90 minutes after treatment demonstrated recanalisation of the infarct-related coronary artery in 8 APSAC-treated patients compared with only 1 placebo-treated patient (p less than 0.02). Repeat coronary arteriography 3 days after treatment showed reocclusion in 1 of the 8 APSAC-treated patients and persistent perfusion in the single patient who reperfused on placebo. All patients with patent vessels at pretreatment coronary arteriography (3 APSAC, 5 placebo) remained patent throughout the study period. There were no haemorrhagic complications related to APSAC therapy. These data confirm that APSAC is a safe, effective thrombolytic agent which, when administered by the intravenous route, resulted in a 53% recanalisation rate.

RCT Entities:   Population Interventions Outcomes