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Sponsors and Collaborators: |
Laval University Eli Lilly and Company Cordis Corporation Quebec Heart Institute |
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Information provided by: | Laval University |
ClinicalTrials.gov Identifier: | NCT00440778 |
HYPOTHESES
Condition | Intervention | Phase |
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Myocardial Infarction Ischemia |
Drug: Abciximab |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial of Early Discharge After Trans-Radial Stenting of Coronary Arteries in Acute Myocardial Infarction: The EASY-MI Pilot Study. |
Enrollment: | 105 |
Study Start Date: | February 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Gr 1 - intracoronary + infusion: Experimental
abciximab bolus 0.25 mg/kg ic + 12 hrs iv infusion
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Drug: Abciximab
100% abciximab bolus dose (0.3 mg/kg) ic or iv vs standard bolus (0.25 mg/kg) ic or iv plus 12-hr infusion
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Gr 2 - intracoronary: Experimental
100% abciximab bolus dose 0.3 mg/kg ic
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Drug: Abciximab
100% abciximab bolus dose (0.3 mg/kg) ic or iv vs standard bolus (0.25 mg/kg) ic or iv plus 12-hr infusion
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Gr 3 - intravenous: Active Comparator
abciximab bolus dose 0.25 mg/kg iv + 12 hrs iv infusion
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Drug: Abciximab
100% abciximab bolus dose (0.3 mg/kg) ic or iv vs standard bolus (0.25 mg/kg) ic or iv plus 12-hr infusion
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Gr 4 - intravenous: Experimental
100% abciximab bolus dose 0.3 mg/kg iv
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Drug: Abciximab
100% abciximab bolus dose (0.3 mg/kg) ic or iv vs standard bolus (0.25 mg/kg) ic or iv plus 12-hr infusion
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OBJECTIVES AND END-POINTS The objectives of the present study are to assess the benefits and safety of 1) a single bolus of abciximab (100% dose) compared with the standard bolus (ca 80% of the total dose) + 12h infusion (ca 20% of the total dose), and 2) intracoronary abciximab bolus administration compared with intravenous route of abciximab administration in primary PCI.
The primary PLATELETS end-points are the percentage of patients with ≥ 95% platelet aggregation inhibition 10 minutes after abciximab bolus (MAX) and the mean platelet aggregation inhibition 10 minutes after abciximab bolus (MEAN).
The secondary CLINICAL end-points of the study are:
The secondary ANGIOGRAPHIC end-points of the study are:
Other exploratory end-points are the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, the cardiac MRI measurements and platelet aggregation inhibition at 6h post-PCI.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient with acute myocardial infarction eligible for primary PCI within 6 h of symptoms: patient must have prolonged, continuous (lasting at least 20 minutes) signs and symptoms of ischemia not eliminated with nitrates and onset within 6 h of randomization, and one of the following:
Exclusion Criteria:
Canada | |
Laval Hospital | |
Quebec, Canada, G1V 4G5 |
Principal Investigator: | Olivier F Bertrand, MD, PhD | Laval Hospital Research Center |
Responsible Party: | Hopital Laval ( Olivier F Bertrand, MD PhD ) |
Study ID Numbers: | EASY-MI |
Study First Received: | February 23, 2007 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00440778 |
Health Authority: | Canada: Health Canada |
Coronary artery stenting Trans-radial Intracoronary |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Abciximab Ischemia Infarction Myocardial Infarction |
Anticoagulants Pathologic Processes Therapeutic Uses Hematologic Agents |
Platelet Aggregation Inhibitors Cardiovascular Diseases Pharmacologic Actions |