Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000557639
Ethics application status
Approved
Date submitted
23/09/2005
Date registered
29/09/2005
Date last updated
29/11/2019
Date data sharing statement initially provided
29/11/2019
Date results information initially provided
29/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The ATACAS Trial: Aspirin and Tranexamic Acid for Coronary Artery Surgery Trial
Scientific 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 [1] 279963 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
ATACAS
Linked study record

Health condition
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. 682 0
Condition category
Condition code
Surgery 757 757 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 672 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Active

Outcomes
Primary outcome [1] 950 0
Primary End Point: Composite: 30-day mortality or major morbidity (myocardial infarction, cardiogenic shock, stroke, pulmonary embolism, cardiac tamponade).
Timepoint [1] 950 0
30 Days
Secondary outcome [1] 1814 0
Blood transfusion
Timepoint [1] 1814 0
30 days
Secondary outcome [2] 1815 0
Re-operation
Timepoint [2] 1815 0
30 days
Secondary outcome [3] 1816 0
Respiratory failure
Timepoint [3] 1816 0
30 days
Secondary outcome [4] 1817 0
Renal failure
Timepoint [4] 1817 0
30 days
Secondary outcome [5] 1818 0
Serious wound infection
Timepoint [5] 1818 0
30 days
Secondary outcome [6] 1819 0
Prolonged hospitalisation.
Timepoint [6] 1819 0
30 days

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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).
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?



Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2006
Actual
17/03/2006
Date of last participant enrolment
Anticipated
Actual
23/10/2015
Date of last data collection
Anticipated
Actual
23/10/2016
Sample size
Target
4600
Accrual to date
Final
4662
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,WA,VIC
Recruitment outside Australia
Country [1] 8711 0
Canada
State/province [1] 8711 0
Ontario, Quebec
Country [2] 8712 0
United Kingdom
State/province [2] 8712 0
England
Country [3] 8713 0
Hong Kong
State/province [3] 8713 0
Hong Kong
Country [4] 8714 0
New Zealand
State/province [4] 8714 0
Auckland

Funding & Sponsors
Funding source category [1] 838 0
Government body
Name [1] 838 0
NHMRC
Country [1] 838 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
Commercial Road
Melbourne Australia
Country
Australia
Secondary sponsor category [1] 705 0
None
Name [1] 705 0
N/A
Address [1] 705 0
Country [1] 705 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2100 0
Geelong Hospital
Ethics committee address [1] 2100 0
Ethics committee country [1] 2100 0
Australia
Date submitted for ethics approval [1] 2100 0
Approval date [1] 2100 0
11/10/2005
Ethics approval number [1] 2100 0
Ethics committee name [2] 2101 0
Monash Medical Centre
Ethics committee address [2] 2101 0
Ethics committee country [2] 2101 0
Australia
Date submitted for ethics approval [2] 2101 0
Approval date [2] 2101 0
09/11/2005
Ethics approval number [2] 2101 0
Ethics committee name [3] 2102 0
St Vincent's Hospital
Ethics committee address [3] 2102 0
Ethics committee country [3] 2102 0
Australia
Date submitted for ethics approval [3] 2102 0
Approval date [3] 2102 0
06/10/2005
Ethics approval number [3] 2102 0
Ethics committee name [4] 2103 0
Austin Health
Ethics committee address [4] 2103 0
Ethics committee country [4] 2103 0
Australia
Date submitted for ethics approval [4] 2103 0
Approval date [4] 2103 0
10/10/2005
Ethics approval number [4] 2103 0
Ethics committee name [5] 2104 0
Flinders Medical Centre
Ethics committee address [5] 2104 0
Ethics committee country [5] 2104 0
Australia
Date submitted for ethics approval [5] 2104 0
Approval date [5] 2104 0
03/04/2007
Ethics approval number [5] 2104 0
Ethics committee name [6] 2106 0
Singapore General Hospital
Ethics committee address [6] 2106 0
Ethics committee country [6] 2106 0
Singapore
Date submitted for ethics approval [6] 2106 0
Approval date [6] 2106 0
Ethics approval number [6] 2106 0

Summary
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
www.atacas.org.au
Trial related presentations / publications
Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussières JS, Wallace S, for the ATACAS investigators and the ANZCA Clinical Trials Network. Aspirin and coronary artery surgery: The ATACAS randomized trial. N Engl J Med. 2016 Feb 25;374(8):728-37

Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper D J, Marasco S, McNeil J, Bussieres JS, McGuinness, S, Byrne, K, Chan MTV, Landoni G, Wallace S, ATACAS Investigators of the ANZCA Clinical Trials Network. Tranexamic acid in patients undergoing coronary artery surgery. N Engl J Med 2017; 376: 136-148.

Myles PS, Smith JA, Kasza J, Silbert B, Jayarajah M, Painter T, Cooper DJ,
Marasco S, McNeil J, Bussières JS, McGuinness S, Byrne K, Chan MTV, Landoni G, Wallace S, Forbes A, for the ATACAS investigators and the ANZCA Clinical Trials Network, Tranexamic Acid in Coronary Artery Surgery: One-Year Results of the ATACAS Trial, The Journal of Thoracic and Cardiovascular Surgery (2018),

Paul S. Myles, Julian A. Smith, Jessica Kasza, Brendan Silbert, Mohandas Jayarajah, Thomas Painter, D. James Cooper, Silvana Marasco, John McNeil, Jean S. Bussieres, , Shay McGuinness, Matthew T. V. Chan, Sophie Wallace and Andrew Forbes, for the ATACAS investigators and the ANZCA Clinical Trials Network. Aspirin in coronary artery surgery: 1-year results of the Aspirin and Tranexamic Acid for Coronary Artery
Surgery trial. The Journal of Thoracic and Cardiovascular Surgery (2018),
Public notes

Contacts
Principal investigator
Name 35829 0
Prof Paul Myles
Address 35829 0
Professor / Director Department of Anaesthesia and Perioperative Medicine Commercial Road Melbourne VIC 3004
Country 35829 0
Australia
Phone 35829 0
+61 39076 3176
Fax 35829 0
Email 35829 0
p.myles@alfred.org.au
Contact person for public queries
Name 9861 0
Prof Professor Paul Myles
Address 9861 0
Professor / Director
Department of Anaesthesia and Perioperative Medicine
Commercial Road
Melbourne VIC 3004
Country 9861 0
Australia
Phone 9861 0
+61 3 92763176
Fax 9861 0
+61 3 92071076
Email 9861 0
p.myles@alfred.org.au
Contact person for scientific queries
Name 789 0
Miss Sophie Wallace
Address 789 0
Research Manager
Perioperative Medicine
Commercial Road
Melbourne VIC 3004
Country 789 0
Australia
Phone 789 0
+61 9076 2651
Fax 789 0
+61 3 92071076
Email 789 0
sophia.wallace@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTranexamic acid in patients undergoing coronary-artery surgery.2017https://dx.doi.org/10.1056/NEJMoa1606424
EmbaseTranexamic acid modulates the immune response and reduces postsurgical infection rates.2019https://dx.doi.org/10.1182/bloodadvances.2019000092
Dimensions AITranexamic acid in coronary artery surgery: One-year results of the Aspirin and Tranexamic Acid for Coronary Artery Surgery (ATACAS) trial2018https://doi.org/10.1016/j.jtcvs.2018.09.113
N.B. These documents automatically identified may not have been verified by the study sponsor.