Abstract 14668: Prospective, Randomized Comparison of 500 mg and 250 mg Acetylsalicylic Acid I.v. and 300 mg p.o. in Patients With Acute Coronary Syndrome (ACUTE Trial)

Background: Current national and international guidelines recommend the use of oral and/or intravenous (IV) acetylsalicylic acid as an alternative mode of application in patients with acute coronary syndrome (ACS) who are unable to swallow. However, acetylsalicylic acid IV has not been investigated in clinical trials and is not available everywhere. Aim: The primary objective of the present open-label, randomized, verum-controlled, parallel-group, phase III study was to demonstrate superiority of 250 or 500 mg acetylsalicylic acid IV treatment over oral treatment with 300 mg acetylsalicylic acid tablet to inhibit thromboxane A2 release at 5 minutes after a single dose of study drug in subjects with ACS with and without ST elevation. Methods: Acetylsalicylic acid naive patients with ACS were randomized into three groups to receive a single dose of acetylsalicylic acid either 300 mg orally, 250 or 500 mg intravenously. ThromboxaneA2 release (measured as the stable serum metabolite thromboxane B2), platelet aggregation and prostacyclin levels were measured 5 and 20 minutes after study drug administration. Patients were followed for 30 days for clinical events. Results: A total of 270 patients were randomized. The results of the primary and secondary endpoints are given in the table. Conclusion: The administration of 250 or 500 mg acetylsalicylic acid intravenously compared to 300 mg orally is associated with a faster and more effective inhibition with respect to thromboxane generation and inhibition of platelet aggregation, without any increase in bleeding complications. Therefore, i.v. administration of acetylsalicylic acid should be preferred in the acute management of patients with ACS.