Status:
COMPLETED
A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI
Lead Sponsor:
Laval University
Collaborating Sponsors:
Eli Lilly and Company
Cordis US Corp.
Conditions:
Myocardial Infarction
Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
HYPOTHESES 1. Bolus administration of total abciximab dose provides superior maximal and mean platelet aggregation inhibition (PAI) compared with standard bolus (0.25 mg/kg) administration. 2. Total ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00440778
Start Date
February 1 2007
End Date
October 1 2008
Last Update
November 24 2011
Active Locations (1)
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1
Laval Hospital
Québec, Quebec, Canada, G1V 4G5