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CTRI Number  CTRI/2012/07/002767 [Registered on: 05/07/2012] Trial Registered Prospectively
Last Modified On: 13/12/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   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.  
Scientific Title of Study   Aspirin and tranexamic acid for coronary artery surgery trial. A collaborative project conducted by the Australian and New Zealand College of Anaesthetist Trials Group (ANZCA TG), and the NHMRC centre for clinical Research Excellence in Therapeutics 
Trial Acronym  ATACAS 
Secondary IDs if Any  
Secondary ID  Identifier 
ACTRN12605000557639   ANZCTR 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajiv Juneja 
Designation  PI - Medanta 
Affiliation   
Address  Medanta-The Medicity Sector – 38, Gurgaon Haryana , India

Gurgaon
HARYANA
122 001
India 
Phone  919717446423  
Fax    
Email  juneja@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rajiv Juneja 
Designation  Principal Investigator  
Affiliation  PI 
Address  Medanta-The Medicity Sector – 38, Gurgaon Haryana 122 001, India

Gurgaon
HARYANA
3004
India 
Phone  61390763176  
Fax  61390768076  
Email  juneja@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Sanjeeta kumari 
Designation  Trial Coordinator 
Affiliation   
Address  Medanta-The Medicity Sector – 38, Gurgaon Haryana , India

Gurgaon
HARYANA
122 001
India 
Phone    
Fax    
Email  Sanjeetakmr@gmail.com  
 
Source of Monetary or Material Support  
National Health and Medical Research Council - Project Grant 
 
Primary Sponsor  
Name  National Health and Medical Research Council 
Address  Level 1 16 Marcus Clarke Street Canberra ACT 2601  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
Canada
Hong Kong
New Zealand
United Kingdom
India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Poonam Malhotra Kapoor  All India Institute of Medical Science  Associate Professor, Department of Cardiac Anaesthesia, All India Institute of Medical Science, New Delhi
New Delhi
DELHI 		 911126588500

drpoonamaiims@gmail.com 
DrDesurkar Vinayak   Mai Mangeshkar Cardiac Centre  Department of Cardiac Surgery Mai Mangeshkar cardiac Centre Deenanath Mangeshkar Hospital Erandvane Pune 411004 India Maharashtra.
Pune
MAHARASHTRA 		 912040151000

devinayak@hotmail.com 
Dr Rajiv Juneja   Medanta-The Medicity  Medanta Institute of Critical Care & Anesthesiology Sector – 38, Gurgaon Haryana 122 001, India
Gurgaon
HARYANA 		 919717446423

juneja@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
All India Institute of Medical Science  Submittted/Under Review 
Mai Mangeshkar Cardiac Centre  Submittted/Under Review 
Medanta  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Undergoing Coronary Artery Bypass Graft,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aspirin  100mg enteric coated, One dose 1-2 hours per operativeely 
Comparator Agent  Normal Saline  0.5ml/kg given at induction of anaesthesia once 
Comparator Agent  Placebo  Oral tablet, pre operative 
Intervention  Tranexamic Acid  50mg/kg over 30 mins at induction of anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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 >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.
 
 
ExclusionCriteria 
Details  1. Poor 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 mol/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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
A composite endpoint including 30-day mortality or major ischaemic morbidity (myocardial infarction, stroke, pulmonary embolism, renal failure, bowel infarction)  30 days and 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
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

 		 30 days and 1 year 
 
Target Sample Size   Total Sample Size="4600"
Sample Size from India="1500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   09/07/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/03/2006 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Myles PS, Smith J, Knight J, Cooper DJ, Silbert B, McNeil J, Esmore DS, Buxton B, Krum H, Forbes A, Tonkin A, and the ATACAS Trial Group. Aspirin and tranexamic acid for coronary artery surgery (ATACAS) trial: rationale and design. Am Heart J 2008; 155:224-230. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   A total of 4,600 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. 
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