Overview

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

Status:
Unknown status
Trial end date:
2013-09-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centro Cardiologico Monzino
Collaborators:
Catholic University, Italy
University of Chieti
Treatments:
Aspirin
Criteria
Inclusion Criteria:

- informed consent of the study signed

- coronary artery bypass graft and / or aortic valve replacement surgery with
bioprostheses

- age between 55 and 80

- ejection fraction > 30%.

Exclusion Criteria:

- excessive bleeding (> 1000mL / 6 h) or the need of re operation for bleeding

- perioperative myocardial infarction

- stroke or renal failure requiring dialysis and need waiting for post-operative
anticoagulation

- patients undergoing coronary artery bypass grafting procedure as a consequence of
failed percutaneous coronary intervention

- patients undergoing off-pump coronary artery bypass graft

- overt kidney or liver disease

- therapies that influence the coagulation

- fertile women