Aspirin and Tranexamic Acid for Coronary Artery Surgery Trial

Phase 1

Conditions: Coronary Artery Bypass Grafting
MedDRA version: 15.0Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2009-015013-46-IT

Lead Sponsor: ALFRED HEALTH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 4600

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 ³70 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 mmol/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 3600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion Criteria

1. Poor (English) language comprehension
2. Clinician preference for antifibrinolytic therapy
3. Urgent surgery for unstable coronary syndromes where for clinical reasons
antiplatelet medication cannot be discontinued
4. Active peptic ulceration
5. Allergy or contraindication to aspirin or tranexamic acid
6. Aspirin therapy within 4 days of surgery
7. Warfarin or clopidogrel therapy within 7 days of surgery, or GIIb/IIIa antagonists
within 24 h of surgery
8. Thrombocytopaenia or any other known history of bleeding disorder
9. Severe renal impairment (serum creatinine >250 mmol/l, or estimated creatinine
clearance <25 ml/min)
10. Recent haematuria
11. Thromboembolic disease relating to: history of postoperative or spontaneous
pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability
(eg. Lupus anticoagulant, protein C deficiency)
12. Pregnancy.