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.

Completed

• Conditions: CABG; heart bypass surgery; 10011082; 10007593

• Registration Number: NL-OMON40015
• Lead Sponsor: Alfred Hospital

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-10-15
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 29

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 70 years and over
* 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 *mol/l or creatinine clearance <45 ml/min)
* Obesity (body mass index >25 kg/m2)
* Pulmonary hypertension (mPAP >25 mmHg)
* Peripheral vascular disease.

Exclusion Criteria

1. Poor (Dutch) 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Composite: 30-day mortality or major morbidity (myocardial infarction,<br /><br>cardiogenic shock, stroke, pulmonary embolism, cardiac tamponade). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Each of the above, plus blood transfusion, re-operation, respiratory failure,<br /><br>renal failure, serious wound infection, prolonged hospitalisation. </p><br>