CompletedPhase 4ACTRN12605000557639

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

A prospective, randomised, double blind, factorial trial testing whether aspirin, tranexamic acid, or both, can reduce mortality and/or major morbidity after elective coronary artery surgery.

Sponsor

The Alfred Hospital

Enrollment

4,600 participants

Start Date

Mar 17, 2006

Study Type

Interventional

Conditions

Patient undergoing elective CABG surgery for any reason, who are at an increased risk of major complications due to their age, cardiac function, comorbidity, or previous cardiac surgery.

Summary

A total of 4,400 people having coronary artery bypass graft surgery will participate in this project. Whilst surgery offers benefit to the majority ofpatients, a small proportion have serious complications (such as heart attack, stroke, infection or even death). Each of these can have a marked effect on quality of life. The purpose of this project is to study the effects of two medications, each of which may reduce complications associated with your heart surgery. The two drugs being tested are aspirin and tranexamic acid (TA). Aspirin and / or TA may protect against some of these complications.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

Written, informed consent. 2. Elective coronary artery surgery. 3. Patient is at increased risk of major complications, defined by any of: Age >75 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;Chronic obstructive pulmonary disease;Renal impairment (creatinine >150 mmol/l);Obesity (body mass index >25 kg/m2);Pulmonary hypertension (mPAP >25 mmHg);Peripheral vascular disease.

Exclusion Criteria1

Poor (English) language comprehension2. Off-pump CABG3. Clinician preference for antifibrinolytic therapy4. Urgent surgery for unstable coronary syndromes5. Active peptic ulceration6. Allergy to aspirin or tranexamic acid7. Other antiplatelet therapy within 7 days of surgery (except GIIb/IIIa antagonists [<24 h])8. Thrombocytopaenia or any other known history of bleeding disorder9. Severe renal impairment (serum creatinine >250 mmol/l)10. Thromboembolic disease11. Pregnancy.

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Interventions

Cessation of the aspirin arm of the study recommended by the steering committee and endorsed by the data saftey monitoring committee. The ATACAS Trial has been established to answer a clinically impo

Cessation of the aspirin arm of the study recommended by the steering committee and endorsed by the data saftey monitoring committee. The ATACAS Trial has been established to answer a clinically important question: Should tranexamic acid (TA), be used in people having heart bypass surgery? Patients will now be randomly allocated to one of 2 treatment groups: Tranexamic Acid; Placebo

Locations(4)

Ontario, Quebec, Canada

England, United Kingdom

Hong Kong, Hong Kong

Auckland, New Zealand

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ACTRN12605000557639