To compare the effects of different aspirin regimens ( 100mg/d, 200mg/d, 100+100 mg b.i.d.) to patients undergoing coronary artery bypass grafting and/or aortic valve replacement with bioprosthesis

Conditions: Coronary Atheroclerosis
MedDRA version: 14.1Level: PTClassification code 10003211Term: Arteriosclerosis coronary arterySystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-001488-40-IT

Lead Sponsor: FONDAZIONE MONZINO CENTRO CARDIOLOGICO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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%.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

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 of 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effects of different aspirin regimens ( 100mg/d, 200mg/d, 100+100 mg b.i.d.) to patients undergoing coronary artery bypass grafting and/or aortic valve replacement with bioprosthesis on platelet thromboxane A2 biosynthesis and on the secretion of new platelets into circulation.;Secondary Objective: To determine whether these patients need a different (shorter) interval of administration in order to completely and permanently inhibit the platelet COX-1;Primary end point(s): variation of the levels of TXB2 and 12-HETE in serum at 12 and 24 hours after administration of aspirin;Timepoint(s) of evaluation of this end point: 12 and 24 hours after administration

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): change in the levels of 11-dehydro TXB2 urinary 8-iso-PGF2 ? urinary, 2-3 dinor-6-chetoPGF1 ?, Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin;Timepoint(s) of evaluation of this end point: 12 and 24 hours after administration