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

Phase 2

• Conditions: Coronary Arteriosclerosis
• Interventions: Drug: Aspirin

• Registration Number: NCT01466452
• Lead Sponsor: Centro Cardiologico Monzino

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-20
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-07
• Last Update Submitted: 2011-11-07
• Study First Posted: 2011-11-08
• Last Update Posted: 2011-11-08
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin 100	Aspirin	-
Aspirin 200	Aspirin	-
Aspirin 100 x 2	Aspirin	-

Primary Outcome Measures

Name	Time	Method
change in the levels of TXB2 in serum at 12 and 24 hours after administration of aspirin	one year
change in the levels of 12-HETE in serum at 12 and 24 hours after administration of aspirin	one year

Secondary Outcome Measures

Name	Time	Method
change in the levels of 11-dehydro TXB2 urinary at 12 and 24 hours after administration of aspirin	one year
change in the levels of 8-iso-PGF2 alpha urinary at 12 and 24 hours after administration of aspirin	one year
change in the levels of 2-3 dinor-6-chetoPGF1 alpha at 12 and 24 hours after administration of aspirin	one year
change in the levels of Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin	one year

Trial Locations

Locations (1)

Centro Cardiologico Monzino, IRCCS; 🇮🇹 Milano, Italy