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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01466452

Acronym

ASABYVALV

Enrollment

Registered

2011-11-08

Start date

2011-09-30

Completion date

2013-09-30

Last updated

2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Arteriosclerosis

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

Interventions

DRUGAspirin

single-dose aspirin in 100 mg 1 tablet every 24 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Italy

Contacts

Primary ContactAlessandro Parolari, MD PhD

alessandro.parolari@ccfm.it+39 025800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026