The ATACAS Trial: Aspirin and Tranexamic Acid for Coronary Artery Surgery Trial

INTERVENTION: Trade Name: Aspirin protect 100mg Product Name: Aspirin Product Code: 16854.01.01 Pharmaceutical Form: Coated tablet Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Trade Name: Cyklokapron injection Product Name: Tranexamic Acid Product Code: PL 00032/0314 Pharmaceutical Form: Route of administration of the placebo: Intravenous drip use (Noncurrent) CONDITION: Coronary Artery Bypass Grafting PRIMARY OUTCOME: Main Objective: i. Should low‐dose aspirin be continued up until the day of Coronary Artery Bypass Graft(CABG) surgery? ii. Should tranexamic acid be used for all at‐risk CABG surgery? Primary end point(s): The primary outcome is all cause mortality at 30 days following surgery. Secondary Objective: Primary Endpoint; A composite endpoint including 30‐day mortality or major ischaemic morbidity (myocardial infarction, stroke, pulmonary embolism, renal failure, bowel infarction) Secondary Endpoints; (i) 30‐day mortality (ii) Ischaemic complications • Myocardial infarction • Stroke • Renal failure • Pulmonary embolism • Bowel infarction (iii) Bleeding complications • Major haemorrhage (re‐operation for bleeding) • Cardiac tamponade • Number of transfused blood product units INCLUSION CRITERIA: 1. Males and females, age 18 years and over 2. Written, informed consent 3. Elective coronary artery surgery (on‐pump or off‐pump) 4. Patient is at increased risk of major complications, defined by any of: • Age = or > 70 years • Left ventricular impairment (fractional area change <20%, ejection fraction <40%, or at least moderate impairment on ventriculography) • Concomitant valvular or aortic surgery • Aneurysmectomy • Repeat cardiac surgery (“re‐do”) • Chronic obstructive pulmonary disease • Renal impairment (se. creatinine >150 micromol/l or creatinine clearance <45 ml/min) • Obesity (body mass index >25 kg/m2) • Pulmonary hypertension (mPAP >25 mmHg) • Peripheral vascular disease. 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 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0