drugset / Trial / NCT01466452

Antiplatelet Effect of Low Doses of Aspirin Taken Every 12 Hours in Patients Undergoing Coronary Artery Bypass Graft and/or Aortic Valve Surgery

NCT01466452

RandomizedParallel-groupOpen-label

Summary

This study is a randomized open label study that implies the administration of asprin according to three different regimens. The aims of the study are: * to establish whether coronary artery bypass surgery and / or aortic valve replacement surgery with bioprostheses is associated with changes in the rate of platelet regeneration that can reduce the effectiveness of aspirin administered at a dose of 100mg/die in terms of inhibition of platelet biosynthesis of thromboxane A2. * to determine whether these patients need a different (shorter) interval of administration in order to completely and permanently inhibit the platelet COX-1. The endpoints of this study are: \- To evaluate the changes in the levels of TXB2 and 12-HETE in serum at 12 and 24 hours after administration of aspirin and the changes in the levels of 11-dehydro TXB2 urinary 8-iso-PGF2 alpha urinary, 2-3 dinor-6-chetoPGF1 alpha, Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin

Timeline

Start
2011-09
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 100 mg
Comparator Aspirin Small molecule 200 mg