CARESS in Acute Myocardial Infarction

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Device: Coronary Angioplasty (PTCA)


Participation Criteria
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Eligibility Criteria
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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: Summation of ST-segment elevation or depression ≥ 15 mm in all 12 electrocardiographic leads or new onset complete left bundle branch block; Previous myocardial infarction (Q- and non Q-wave); Killip Class 2 or 3; LV ejection fraction at transthoracic ultrasound < 40%. Exclusion Criteria: Inability to provide informed consent; Age > 75 years CABG or PCI procedure in past history involving the infarct-related artery; Participation in another study with any investigational drug or device within the previous 30 days; Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer); 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); 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); Severe hepatic disease; Patients with acute or chronic renal impairment (serum creatinine > 2.0 mg % or 200 mg/l or creatinine clearance < 30 ml/min); Transmural MI in different location within the previous week; Previous administration of thrombolytics within 7 days; Intolerance or contraindications to ASA or Clopidogrel; Known leucopenia, defined as a leukocyte count of < 3.500 White Blood Cells (WBC)/ml Known neutropenia, defined as < 1000 neutrophils / ml; Known thrombocytopenia (< 100.000 platelets / ml ); Documented active peptic ulcer or upper gastrointestinal bleeding within the previous 6 months; Previous hemorrhagic stroke; Previous ischemic cerebrovascular event within 3 months; Intracranial neoplasm; Recent major surgery at risk of bleeding; Episodes of uncontrolled hypertension (> 180/110 mmHg despite treatment) in past 2 years; Administration of oral anticoagulants within the previous 7 days unless INR ≤ 1.2; Severe recent trauma; Known or possible pregnancy; Absence of suitable vascular access (diffuse peripheral arterial disease); Basal ECG changes which make identification of ST-segment elevation impossible (i.e.: ventricular activation from artificial pacemaker, etc.).

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Coronary Angioplasty (PTCA)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare 30 days incidence of the composite end-point of: mortality, reinfarction and refractory ischemia in the two arms of the study. |  | 30 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare 1 year composite end-point of: mortality, reinfarction, refractory ischemia, hospital readmission because of heart failure in the two arms; |  | 1 Year | 
| Compare the resource use at 30 days and 1 year, including days in CCU, MICU or general ward, cost of catheterization and PTCA, drugs, ambulance service during index hospitalization and subsequent hospital admissions for reAMI |  | 30 Day and 1 Year | 
| Compare the incidence of in-hospital stroke and bleeding complications in the two arms. |  | 30 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMI, stent, PTCA, abciximab, reteplase, combo therapy