Clinical 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Arteriosclerosis
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
Collaborators: name: Catholic University, Italy
name: University of Chieti
First posted: 2011-11-08
Enrollment: 99
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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


Eligibility 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

Primary outcomes:
measure: change in the levels of TXB2 in serum at 12 and 24 hours after administration of aspirin
timeFrame: one year
measure: change in the levels of 12-HETE in serum at 12 and 24 hours after administration of aspirin
timeFrame: one year
Secondary outcomes:
measure: change in the levels of 11-dehydro TXB2 urinary at 12 and 24 hours after administration of aspirin
timeFrame: one year
measure: change in the levels of 8-iso-PGF2 alpha urinary at 12 and 24 hours after administration of aspirin
timeFrame: one year
measure: change in the levels of 2-3 dinor-6-chetoPGF1 alpha at 12 and 24 hours after administration of aspirin
timeFrame: one year
measure: change in the levels of Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin
timeFrame: one year
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Centro Cardiologico Monzino, IRCCS
Study officials:
References: