RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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RadIal Versus Femoral Randomized InvEstigation in ST Elevation Acute Coronary Syndrome

Conditions
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Coronary Artery Disease, Acute Coronary Syndrome, ST Elevation Acute Myocardial Infarction

Intervention / Treatment
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* Procedure: Femoral approach
* Procedure: Radial approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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). 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radial<br>group of patients undergoing primary angioplasty by transradial approach | Procedure: Radial approach<br>* diagnostic and interventional procedures by radial artery access<br>* Other names: transradial;|
| Active Comparator: Femoral<br>group of patients undergoing primary angioplasty by transfemoral approach | Procedure: Femoral approach<br>* diagnostic and interventional procedures by femoral artery access<br>* Other names: transfemoral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net Adverse Clinical Event | Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding | 30-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net Adverse Clinical Event | Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding | 1-year | 
| Individual components of NACE | Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding | 30-day | 
| Individual components of NACE | Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding | 1-year | 
| Total procedural and fluoroscopy times for the index procedure | Comparison of procedural and fluoroscopy times between the two study groups | 1 day | 
| Hospital stay | Days of hospitalization | 30-day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radial access, primary angioplasty, trial, randomization, outcome