Aspirin is an antiplatelet drug that affects the ability of platelets in the blood to bind together and form clots. It is used routinely in patients with or at risk of heart disease and after surgery to bypass blocked arteries supplying the heart (coronary artery bypass graft, CABG, surgery). Following CABG surgery aspirin is used to reduce the progression of fatty deposits in the arteries to the heart to help prevent bypass grafts from blocking and improve patient survival.
Conditions
Interventions
Trade Name: Aspirin
Product Name: Aspirin
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: Aspirin
Concentration unit: mg mi
Sponsors
Cardiff and Vale NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing first time elective coronary artery bypass grafting only Aspirin to be stopped for at least 5 days prior to surgery 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with bleeding or platelet disorders Re-do surgery Age over 80 years Emergency CABG for myocardial infarction Off pump coronary artery bypass grafting Patients stopping anti platelet therapy less then 5 days before the operation Patient taking heparin / low-molecular heparin till the day of the operation Patient stopping Warfarin less then 3 day before operation Patients with a platelet count <150 x 103/ ml Patients with Haematocrit < 35% Bleeding disorders in early postoperative period Patients with contraindications for aspirin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect on platelet function of early high dose aspirin following Coronary Artery Bypass Grafting (CABG) compared to late low dose. The study will compare existing practice and will not impact upon or change the prescription of the aspirin. Aspirin will be given according to randomization into the two aspirin treatment groups. Group I: Early High Dose Regime: 300 mg Aspirin PR 4 hrs post-operatively in Cardiac Intensive Care Unit 300 mg Aspirin OD PO on each day postoperatively at the morning Discharged on 300mg OD PO Group II: Low Dose Regime: 150 mg Aspirin OD PO from day 1 post-operatively 150 mg Aspirin OD PO on each day postoperatively at the morning Discharged on 150 mg ; Secondary Objective: Secondary endpoints include the identification of aspirin related side effects, post-operative heart related complications/bleeding and recovery. One year follow up · Death · Myocardial infarct/Angina · Stroke / TIA · PTCA / stent / re-do · Side effects of Aspirin ;Primary end point(s): To evaluate the effect of aspirin on platelet function as demonstrated through the platelet function PFA 100 test. Aspirin therapy only prolongs the collagen/epinephrine closure time in the PFA 100. Col/Epi 82-150 seconds (upper limit 165 seconds). There is platelet dysfuction with a closure time of greater than 165 seconds. The closure times will be analysed with 4ml blood samples taken with citrate vacutainer system preoperatively, immediately postoperatively and at one, three and five days following surgery in accordance with routine clinical practice | — |
Countries
United Kingdom
Outcome results
None listed