Status:
UNKNOWN
RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome
Lead Sponsor:
Policlinico Casilino ASL RMB
Conditions:
Coronary Artery Disease
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of net adverse clinical outcomes (NACE) of transfemoral vs. transradial approach for the treatment of pa...
Detailed Description
Prospective, randomized, double arm study. The study population will include all consecutive patients presenting with a ST-elevation Acute Coronary Syndrome and candidates for primary percutaneous cor...
Eligibility Criteria
Inclusion
- Subject is \>18 years old with recent acute ST-elevation acute coronary syndrome (STEACS) requiring emergent coronary angiography.
- Patient has no contraindication to percutaneous arterial access by both and transfemoral route.
- Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
- Patient and the treating physician agree that the subject will comply with all follow-up evaluations.
Exclusion
- Subject's age is \<18 years and he has no acute ST-elevation myocardial infarction (ST elevation of a least 0.1 mV in ≥2 extremity leads or at least 0.2 mV in ≥2 precordial leads).
- Subject has had a recent stroke or TIA (\<4 weeks), irrespective of age.
- Patient has an international normalized ratio (INR) \> 2.0, or other severe bleeding diathesis
- The patient is pregnant or breastfeeding.
- Known allergies to: aspirin, clopidogrel and ticlopidine, heparin, IIb/IIIa inhibitors, stainless steel, or contrast agent (which cannot be adequately premedicated).
- Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- Prior participation in this study.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
1001 Patients enrolled
Trial Details
Trial ID
NCT01420614
Start Date
January 1 2009
End Date
July 1 2012
Last Update
February 7 2012
Active Locations (4)
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1
Università di Modena e Reggio Emilia
Modena, Modena, Italy, 41124
2
Ospedale Sandro Pertini
Rome, Rome, Italy, 00100
3
Policlinico Casilino
Rome, Rome, Italy, 00100
4
University of Turin, San Giovanni Battista Hospital
Turin, Turin, Italy, 10100