This trial is active, not recruiting.

Conditions coronary artery disease, acute coronary syndrome, st elevation acute myocardial infarction
Treatments femoral approach, radial approach
Sponsor Policlinico Casilino ASL RMB
Start date January 2009
End date July 2011
Trial size 1001 participants
Trial identifier NCT01420614, PC-03ER


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 patients with ST-elevation acute coronary syndrome (STEACS) undergoing primary angioplasty

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
group of patients undergoing primary angioplasty by transradial approach
radial approach transradial
diagnostic and interventional procedures by radial artery access
(Active Comparator)
group of patients undergoing primary angioplasty by transfemoral approach
femoral approach transfemoral
diagnostic and interventional procedures by femoral artery access

Primary Outcomes

Net Adverse Clinical Event
time frame: 30-day

Secondary Outcomes

Net Adverse Clinical Event
time frame: 1-year
Individual components of NACE
time frame: 30-day
Individual components of NACE
time frame: 1-year
Total procedural and fluoroscopy times for the index procedure
time frame: 1 day
Hospital stay
time frame: 30-day

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Subject is >18 years old with recent acute ST-elevation acute coronary syndrome (STEACS) requiring emergent coronary angiography. 2. Patient has no contraindication to percutaneous arterial access by both and transfemoral route. 3. 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. 4. Patient and the treating physician agree that the subject will comply with all follow-up evaluations. Exclusion Criteria: 1. 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). 2. Subject has had a recent stroke or TIA (<4 weeks), irrespective of age. 3. Patient has an international normalized ratio (INR) > 2.0, or other severe bleeding diathesis 4. The patient is pregnant or breastfeeding. 5. Known allergies to: aspirin, clopidogrel and ticlopidine, heparin, IIb/IIIa inhibitors, stainless steel, or contrast agent (which cannot be adequately premedicated). 7.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. 8.Prior participation in this study.

Additional Information

Official title RadIal Versus Femoral Randomized InvEstigation in ST Elevation Acute Coronary Syndrome
Principal investigator Ernesto Lioy, MD
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 coronary intervention, who agree and provide written informed consent for the study. Before arterial stick for percutaneous access, patients will be randomized according to sealed numbered envelopes. Subsequently, arterial access will be obtained and the diagnostic/interventional procedure will be performed according to routine clinical practice, leaving ancillary medications, choice of devices and means of hemostasis at the physician's discretion. In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by Policlinico Casilino ASL RMB.