Once daily vs twice daily aspirin in patients after a heart operation

Antiplatelet effects of once versus twice daily dosing of aspirin after coronary artery bypass grafting

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002233-19-SE

Enrollment

Registered

2011-09-07

Start date

2011-10-14

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Patients having successfully undergone coronary artery bypass graft (CABG) surgery

Interventions

Trade Name: Trombyl Product Name: Trombyl Product Code: 11423 (for 75 mg) 11063 (for 160 mg) Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Stable CAD patients scheduled to undergo elective CABG surgery - Willing to participate and able to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - Patients taking drugs other than aspirin that are known to influence platelet function, including nonsteroidal anti-inflammatory drugs (NSAIDs, including COX-2 selective anti-inflammatory drugs), GPIIbIIIa inhibitors, clopidogrel, dipyridamole, warfarin or acenocoumarol within 7 days of enrolment - Hemorrhagic diathesis or known platelet dysfunction - Patients with chronic renal failure requiring dialysis - Patients with a platelet count outside the 100 000 to 450 000/µL range - Patients with severe anaemia (Haemoglobin < 8g/dl)

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to investigate the impact on platelet function of increasing either the aspirin dose (from 75 mg to 160 mg) or dosing frequency (to 75 mg BID) over 3 months in patients undergoing elective CABG surgery. ;Secondary Objective: 1. To evaluate inhibition of the COX pathway functionally through assessment of platelet aggregation in response to arachidonic acid and collagen in whole blood before (with 75 mg aspirin OD), and at various time points after CABG surgery with three different dosages of aspirin, 75 mg OD, 75 mg BID or 160 mg OD 2. To evaluate inhibition of the COX pathway pharmacologically through serum TxB2 levels (a stable metabolite of TxA2) before, and at various time points after CABG surgery with three different dosages of aspirin, 75 mg OD, 75 mg BID or 160 mg OD 3. To determine whether platelet turnover impacts on the efficacy of the different dosing regimens to induce sustained platelet inhibition 4. To evaluate possible relationships between the antiplatelet effects of different aspirin dosing strategies and inflammatory biomarkers following CABG surgery;Primary end point(s): Inhibition of the COX pathway functionally through assessment of platelet aggregation in response to arachidonic acid and collagen in whole blood ;Timepoint(s) of evaluation of this end point: Before surgery, before hospital discharge (days 4-7 after surgery), after 4 weeks of therapy and after 3(-4) months of therapy	—

Measure

Time frame

Main Objective: The main objective of this study is to investigate the impact on platelet function of increasing either the aspirin dose (from 75 mg to 160 mg) or dosing frequency (to 75 mg BID) over 3 months in patients undergoing elective CABG surgery. ;Secondary Objective: 1. To evaluate inhibition of the COX pathway functionally through assessment of platelet aggregation in response to arachidonic acid and collagen in whole blood before (with 75 mg aspirin OD), and at various time points after CABG surgery with three different dosages of aspirin, 75 mg OD, 75 mg BID or 160 mg OD 2. To evaluate inhibition of the COX pathway pharmacologically through serum TxB2 levels (a stable metabolite of TxA2) before, and at various time points after CABG surgery with three different dosages of aspirin, 75 mg OD, 75 mg BID or 160 mg OD 3. To determine whether platelet turnover impacts on the efficacy of the different dosing regimens to induce sustained platelet inhibition 4. To evaluate possible relationships between the antiplatelet effects of different aspirin dosing strategies and inflammatory biomarkers following CABG surgery;Primary end point(s): Inhibition of the COX pathway functionally through assessment of platelet aggregation in response to arachidonic acid and collagen in whole blood ;Timepoint(s) of evaluation of this end point: Before surgery, before hospital discharge (days 4-7 after surgery), after 4 weeks of therapy and after 3(-4) months of therapy

—

Secondary

Measure	Time frame
Secondary end point(s): - Inhibition of the COX pathway pharmacologically through serum TxB2 levels (a stable metabolite of TxA2) - Platelet turnover Inflammatory biomarkers - Bleeding symptoms;Timepoint(s) of evaluation of this end point: Before surgery, before hospital discharge (days 4-7 after surgery), after 4 weeks of therapy and after 3(-4) months of therapy	—

Countries

Sweden

Contacts

Public ContactClinical Pharmacology Unit

Karolinska Institutet

paul.hjemdahl@ki.se46851775293

Outcome results

None listed

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