A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI (EASY-MI)
Myocardial Infarction, Ischemia
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Coronary artery stenting, Trans-radial, Intracoronary
Eligibility Criteria
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:
- ST-segment elevation ≥ 2 mm in 2 or more contiguous precordial ECG leads (anterior infarction)
- 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)
- ST-segment elevation ≥ 1 mm in 2 or more contiguous limb ECG leads (other infarction)
- New or presumably new left bundle branch block (LBBB)
- Patient must be > 18 years of age.
- Patient and treating interventional cardiologist agree for randomization.
- Patient will be informed of the randomization process and will sign an informed consent.
- Diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach.
- The culprit lesion can be identified on a native coronary vessel, which is suitable for primary PCI with stent implantation.
Exclusion Criteria:
- Patient has received thrombolytic therapy (within the last 4 weeks) and is referred for rescue PCI
- Concurrent participation in other investigational study
- Femoral sheath (artery)
- Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for at least 12 months
- Any significant blood dyscrasia, diathesis or INR > 2.0
- 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.
- Any glycoprotein IIb-IIIa inhibitors use in the previous 30 days
- Uncontrolled high blood pressure i.e. systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg.
- Life expectancy less than 6 months owing to non-cardiac cause
- Infarction caused by in-stent thrombosis or restenosis
- Cardiogenic shock evident before randomization
Sites / Locations
- Laval Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Experimental
Gr 1 - intracoronary + infusion
Gr 2 - intracoronary
Gr 3 - intravenous
Gr 4 - intravenous
abciximab bolus 0.25 mg/kg ic + 12 hrs iv infusion
100% abciximab bolus dose 0.3 mg/kg ic
abciximab bolus dose 0.25 mg/kg iv + 12 hrs iv infusion
100% abciximab bolus dose 0.3 mg/kg iv