CARESS in Acute Myocardial Infarction

Inclusion Criteria:

• ECG with ST-elevation (≥ 1mm in at least 2 ECG limb leads or ≥ 2 mm in 2 contiguousprecordial leads) AMI within <12 hours from symptoms onset fulfilling 1 or more of thefollowing criteria of “high risk”:

1. Summation of ST-segment elevation or depression ≥ 15 mm in all 12 electrocardiographicleads or new onset complete left bundle branch block;

2. Previous myocardial infarction (Q- and non Q-wave);

3. Killip Class 2 or 3;

4. LV ejection fraction at transthoracic ultrasound < 40%.

Exclusion Criteria:

1. Inability to provide informed consent;

2. Age > 75 years

3. CABG or PCI procedure in past history involving the infarct-related artery;

4. Participation in another study with any investigational drug or device within theprevious 30 days;

5. Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer);

6. Cardiogenic shock (hypotension with Systolic Blood Pressure (SBP) < 90 mmHg andtachycardia > 100 beats / min, not due to hypovolemia and requiring inotropic supportor balloon counterpulsation);

7. Need for concomitant major surgery (e.g. valve surgery or resection of aortic or leftventricular aneurysm, carotid endarterectomy, abdominal aortic aneurysm surgery,congenital heart disease etc);

8. Severe hepatic disease;

9. Patients with acute or chronic renal impairment (serum creatinine > 2.0 mg % or 200mg/l or creatinine clearance < 30 ml/min);

10. Transmural MI in different location within the previous week;

11. Previous administration of thrombolytics within 7 days;

12. Intolerance or contraindications to ASA or Clopidogrel;

13. Known leucopenia, defined as a leukocyte count of < 3.500 White Blood Cells (WBC)/ml

14. Known neutropenia, defined as < 1000 neutrophils / ml;

15. Known thrombocytopenia (< 100.000 platelets / ml );

16. Documented active peptic ulcer or upper gastrointestinal bleeding within the previous 6 months;

17. Previous hemorrhagic stroke;

18. Previous ischemic cerebrovascular event within 3 months;

19. Intracranial neoplasm;

20. Recent major surgery at risk of bleeding;

21. Episodes of uncontrolled hypertension (> 180/110 mmHg despite treatment) in past 2years;

22. Administration of oral anticoagulants within the previous 7 days unless INR ≤ 1.2;

23. Severe recent trauma;

24. Known or possible pregnancy;

25. Absence of suitable vascular access (diffuse peripheral arterial disease);

26. Basal ECG changes which make identification of ST-segment elevation impossible (i.e.:ventricular activation from artificial pacemaker, etc.).