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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

Antiplatelet effect of low doses of aspirin taken every 12 hours in patients undergoing coronary artery bypass graft and / or aortic valve replacement surgery with bioprostheses -

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-001488-40-IT
Enrollment
Unknown
Registered
2012-03-06
Start date
2011-09-01
Completion date
Unknown
Last updated
2012-09-25

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

Conditions

Coronary Atheroclerosis MedDRA version: 14.1 Level: PT Classification code 10003211 Term: Arteriosclerosis coronary artery System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: CARDIOASPIRIN*30CPR GAST 100MG Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: ACETYLSALICYLIC ACID CAS Number: 50-78-2 Concentration unit: mg milligram(s) Concentration

Sponsors

FONDAZIONE MONZINO CENTRO CARDIOLOGICO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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%. 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Italy

Contacts

Public ContactREFERENTE OSSC

CENTRO CARDIOLOGICO MONZINO

atanasio.nonis@ieo.it02 57 48 98 48

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026