Myocardial Infarction
Conditions
Keywords
AMI, stent, PTCA, abciximab, reteplase, combo therapy
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 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
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.
Interventions
DEVICECoronary Angioplasty (PTCA)
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Eli Lilly and Company
Biotronik SE & Co. KG
Società Italiana di Cardiologia Invasiva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France, Italy, Poland
Outcome results
None listed