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Sponsors and Collaborators: |
Società Italiana di Cardiologia Invasiva Royal Brompton & Harefield NHS Foundation Trust Eli Lilly and Company Biotronik SE & Co. KG |
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Information provided by: | Società Italiana di Cardiologia Invasiva |
ClinicalTrials.gov Identifier: | NCT00220571 |
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:
Condition | Intervention | Phase |
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Myocardial Infarction |
Device: Coronary Angioplasty (PTCA) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction |
Enrollment: | 600 |
Study Start Date: | May 2003 |
Study Completion Date: | March 2007 |
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.
Ages Eligible for Study: | up to 75 Years |
Genders Eligible for Study: | Both |
Accepts 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”:
Exclusion Criteria:
Principal Investigator: | Leonardo Bolognese, MD, Ph D | Ospedale San Donato - Arezzo Italy |
Principal Investigator: | Gabriel P. Steg, MD. Ph D | Hopital Bichat - Paris France |
Principal Investigator: | Darius Dudek, MD, Ph D | Jagellonian University Krakow Poland |
Study Chair: | Carlo Di Mario, MD | Royal Brompton and Harefield Hospital - London UK |
Study ID Numbers: | IIT(IT) H4S-IT-O038, 2003OE001B |
Study First Received: | September 13, 2005 |
Last Updated: | July 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00220571 History of Changes |
Health Authority: | Italy: Ministry of Health; France: Ministry of Health; Poland: Ministry of Health |
AMI stent PTCA |
abciximab reteplase combo therapy |
Necrosis Heart Diseases Reteplase Myocardial Ischemia Vascular Diseases |
Abciximab Ischemia Infarction Myocardial Infarction |
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |