Status:
COMPLETED
A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI and Rescue-PCI
Lead Sponsor:
Olivier F. Bertrand
Collaborating Sponsors:
Eli Lilly and Company
Cordis US Corp.
Conditions:
Myocardial Infarction
Ischemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
* Abciximab administration is safe and reduces ischemic complications in patients undergoing rescue PCI after failed thrombolysis compared to placebo. * Abciximab improves angiographic scores and vent...
Detailed Description
OBJECTIVES AND END-POINTS The objectives of the present pilot study are to assess 1) the benefits and safety of abciximab i.c. or i.v. compared to placebo in rescue PCI and trans-radial approach, 2) ...
Eligibility Criteria
Inclusion
- Patient with acute myocardial infarction eligible for rescue PCI within 24 hrs of symptoms.
- Failed thrombolysis (defined as less than 50% reduction of ST-elevation at 90 min ECG in the lead with previous maximal ST-segment elevation).
- Patient \> 18 years old.
- 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 transradial/transulnar approach.
- The culprit lesion in a native coronary artery can identified and is suitable for immediate angioplasty and stent implantation.
Exclusion
- Age \> 75 years old
- Body weight \< 65 kg
- Concurrent participation in other investigational study
- Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12 months
- Any significant blood dyscrasia, diathesis or INR \> 2.0.
- Any clinical contraindication to abciximab administration i.e. known structural intracranial lesion, thrombocytopenia (\< 100,000), hemoglobin level \< 10 g/dl
- Patient has received more than one dose of thrombolytic within 24 hours of symptoms
- Previous treatment with glycoproteins IIb-IIIa inhibitors within 30 days
- Perceived increased risk of intracranial or severe bleeding i.e. previous stroke/TIA, alteration of consciousness, recent trauma or major surgery.
- 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
- Evident cardiogenic shock
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00440895
Start Date
February 1 2007
End Date
May 1 2013
Last Update
May 8 2013
Active Locations (1)
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1
Laval Hospital
Québec, Quebec, Canada, G1V 4G5