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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 000789
ACTR Number: ACTRN12605000557639
Trial Status: Registered
Date Submitted: 23/09/2005
Date Registered: 29/09/2005

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Public title: The ATACAS Trial: Aspirin and Tranexamic Acid for Coronary Artery Surgery Trial
ANZCTR registration title: 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.
Secondary ID: 
UTN:
Trial acronym: ATACAS

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Health condition(s) or problem(s) studied:
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. 
Condition category: Condition code:
Surgery Other surgery 

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Description of intervention(s) / exposure: The ATACAS Trial has been established to answer a clinically important question: Should aspirin or tranexamic acid (TA), or both, be used in people having heart bypass surgery?

Design: Large, multi-centre, prospective, randomised, double blind, 2 X 2 factorial trial. Patients will be randomly allocated to one of 4 treatment groups: Aspirin;
Tranexamic Acid;
Aspirin + Tranexamic Acid
Intervention code:Treatment: drugs 
Comparator / control treatment: Placebo
Control group: Active

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Primary outcome:Primary End Point: Composite: 30-day mortality or major morbidity (myocardial infarction, cardiogenic shock, stroke, pulmonary embolism, cardiac tamponade). 
Timepoint:30 Days 
Secondary outcome 1:Blood transfusion 
Timepoint:30 days 
Secondary outcome 2:Re-operation 
Timepoint:30 days 
Secondary outcome 3:Respiratory failure 
Timepoint:30 days 
Secondary outcome 4:Renal failure 
Timepoint:30 days 
Secondary outcome 5:Serious wound infection 
Timepoint:30 days 
Secondary outcome 6:Prolonged hospitalisation. 
Timepoint:30 days 

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Key inclusion criteria: 1. 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.
Minimum Age: 18 Years
Maximum Age: Not stated
Gender: Both males and females
Healthy volunteers? No
Key exclusion criteria: 1. 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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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Concealment of allocation will be achieved by providing active and matched-placebo medications. These are Bayer (aspirin) and Pharmacia (TA, Cyklokapron).
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Randomisation is done using IVRS through Monash University
Masking / blinding: Blinded (masking used)
Who is/are masked/blinded:
Assignment: Factorial
Other design features (specify):
Type of endpoint(s): Safety/efficacy

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Phase Phase 4
Anticipated or actual date of first participant enrolement: 1/03/2006
Target sample size: 4600
Recruitment status: Open to recruitment

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Funding source:Government funding body e.g. Australian Research Council 
Name:NHMRC 
Address:Australia 
Country:Australia 
Primary sponsor: Hospital
Name: The Alfred Hospital
Address: Commercial Road
Melbourne Australia
Country: Australia
Secondary sponsor:None 
Name:N/A 
Address: 
Country: 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:Geelong Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 2:Monash Medical Centre 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 3:St Vincent's Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 4:Austin Health 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 5:Flinders Medical Centre 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 6:Westmead Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 7:Singapore General Hospital 
Address: 
Country:Singapore 
Date of approval: 
HREC Number: 
Countries of recruitment:Australia 
Brief 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.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Professor Paul Myles
Address: Professor / Director
Department of Anaesthesia and Perioperative Medicine
Commercial Road
Melbourne VIC 3004
Country: Australia
Tel: +61 3 92763176
Fax: +61 3 92071076
Email: p.myles@alfred.org.au

Contact person for scientific queries
Name: Sophie Wallace
Address: Research Manager
Perioperative Medicine
Commercial Road
Melbourne VIC 3004
Country: Australia
Tel: +61 9076 2651
Fax: +61 3 92071076
Email: sophia.wallace@alfred.org.au

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