EASY-MI: A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI
Study Details
Study Description
Brief Summary
HYPOTHESES
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Bolus administration of total abciximab dose provides superior maximal and mean platelet aggregation inhibition (PAI) compared with standard bolus (0.25 mg/kg) administration.
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Total dose of abciximab can be given as a single bolus and is more effective than bolus (0.25 mg/kg) + 12 hrs infusion in terms of acute and mid-term angiographic and clinical results.
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Intracoronary (ic) abciximab administration is more effective than intravenous (iv) route of administration in terms of acute and mid-term angiographic and clinical results.
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There is a relationship between PAI and angiographic perfusion scores.
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Routine use of sirolimus-eluting stents (Cypher, Cordis) in primary-PCI is associated with a low rate of target vessel revascularization and complications.
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Cardiac MRI early and late after primary-PCI provides detailed information on myocardial injury and irreversible necrosis, which are correlated with angiographic perfusion scores.
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After uncomplicated trans-radial PCI, patients can be retransferred early to their referring center.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Detailed Description
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:
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The composite of death, stroke, repeat myocardial infarction, urgent target vessel revascularization and major bleedings at 30 days following primary PCI.
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The composite of cardiovascular death, repeat myocardial infarction and repeat target vessel revascularization at 6-months follow-up.
The secondary ANGIOGRAPHIC end-points of the study are:
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The proportion of patients having myocardial blush grade 2-3 and TIMI 3 score at the end of PCI in the culprit vessel.
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The restenosis rate (diameter stenosis ≥ 50%) and late loss in the culprit vessel at 6-months follow-up.
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Gr 1 - intracoronary + infusion abciximab bolus 0.25 mg/kg ic + 12 hrs iv infusion |
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
Other Names:
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Experimental: Gr 2 - intracoronary 100% abciximab bolus dose 0.3 mg/kg ic |
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
Other Names:
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Active Comparator: Gr 3 - intravenous abciximab bolus dose 0.25 mg/kg iv + 12 hrs iv infusion |
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
Other Names:
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Experimental: Gr 4 - intravenous 100% abciximab bolus dose 0.3 mg/kg iv |
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients with at least 95% platelet aggregation inhibition, and mean platelet aggregation inhibition. [10 min after bolus of abciximab]
Secondary Outcome Measures
- Composite of death, stroke, repeat MI, urgent target vessel revascularization and major bleedings at 30 days following primary PCI. [30 days]
- Composite of cardiovascular death, repeat MI and repeat target vessel revascularization at 6-month follow-up. [6 months]
- Proportion of patients having myocardial blush grade 2-3 and TIMI 3 score at the end of PCI in the culprit vessel. [At end of PCI]
- Restenosis rate (diameter stenosis equal or higher than 50%) and late loss in the culprit vessel at 6-month follow-up. [6 months]
- Exploratory end-points: feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, cardiac MRI measurements and platelet aggregation inhibition at 6hr post-PCI. [At 6hr post-PCI]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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:
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ST-segment elevation ≥ 2 mm in 2 or more contiguous precordial ECG leads (anterior infarction)
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ST-segment depression ≥ 2 mm in V1, V2 or V2, V3 with reciprocal 1 mm ST-elevation in II, augmented unipolar foot (left leg) lead (AVF), and V6 (true posterior infarction)
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ST-segment elevation ≥ 1 mm in 2 or more contiguous limb ECG leads (other infarction)
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New or presumably new left bundle branch block (LBBB)
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Patient must be > 18 years of age.
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Patient and treating interventional cardiologist agree for randomization.
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Patient will be informed of the randomization process and will sign an informed consent.
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Diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach.
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The culprit lesion can be identified on a native coronary vessel, which is suitable for primary PCI with stent implantation.
Exclusion Criteria:
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Patient has received thrombolytic therapy (within the last 4 weeks) and is referred for rescue PCI
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Concurrent participation in other investigational study
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Femoral sheath (artery)
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Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for at least 12 months
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Any significant blood dyscrasia, diathesis or INR > 2.0
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Any clinical contraindication to abciximab (ReoPro®) administration i.e. known structural intracranial lesion, thrombocytopenia < 100,000, active or recent bleeding or hemoglobin level known < 10 g/dl.
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Any glycoprotein IIb-IIIa inhibitors use in the previous 30 days
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Uncontrolled high blood pressure i.e. systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg.
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Life expectancy less than 6 months owing to non-cardiac cause
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Infarction caused by in-stent thrombosis or restenosis
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Cardiogenic shock evident before randomization
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Laval Hospital | Quebec | Canada | G1V 4G5 |
Sponsors and Collaborators
- Laval University
- Eli Lilly and Company
- Cordis Corporation
- Quebec Heart Institute
Investigators
- Principal Investigator: Olivier F Bertrand, MD, PhD, Laval Hospital Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EASY-MI