CARESS in Acute Myocardial Infarction

Società Italiana di Cardiologia Invasiva

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction

Treatments: Device: Coronary Angioplasty (PTCA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00220571

IIT(IT) H4S-IT-O038

2003OE001B

Details and patient eligibility

About

The aim of this study conducted in patients with high risk ST-segment elevation AMI admitted to hospitals with no PTCA facilities is to compare the effects on clinical outcome and cost-effectiveness of two reperfusion strategies:

• Fibrinolytic therapy with Abciximab and half-dose Reteplase, with rescue PTCA in case of lack of reperfusion
• Elective referral for "facilitated" PTCA after early administration of Abciximab and half dose of Reteplase

Full description

All patients with ST-segment elevation AMI admitted within 12 hours from symptoms onset will be screened to enter in this study. Data of patients with ST-segment elevation AMI within 12 hours from symptoms onset who do not meet the inclusion criteria or do not sign the informed consent form are entered into a dedicated registry.

Enrollment: 600 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ECG with ST-elevation (≥ 1mm in at least 2 ECG limb leads or ≥ 2 mm in 2 contiguous precordial leads) AMI within <12 hours from symptoms onset fulfilling 1 or more of the following criteria of "high risk":

1. Summation of ST-segment elevation or depression ≥ 15 mm in all 12 electrocardiographic leads 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 the previous 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 and tachycardia > 100 beats / min, not due to hypovolemia and requiring inotropic support or balloon counterpulsation);
7. Need for concomitant major surgery (e.g. valve surgery or resection of aortic or left ventricular 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 200 mg/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 2 years;
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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)