Status:
COMPLETED
CARESS in Acute Myocardial Infarction
Lead Sponsor:
Società Italiana di Cardiologia Invasiva
Collaborating Sponsors:
Royal Brompton & Harefield NHS Foundation Trust
Eli Lilly and Company
Conditions:
Myocardial Infarction
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE3
Brief Summary
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 o...
Detailed 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 sym...
Eligibility Criteria
Inclusion
- \- 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
- 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.).
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00220571
Start Date
May 1 2003
End Date
March 1 2007
Last Update
July 3 2007
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