RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome

Not Applicable

• Conditions: Acute Coronary Syndrome; ST Elevation Acute Myocardial Infarction; Coronary Artery Disease
• Interventions: Procedure: Radial approach; Procedure: Femoral approach

• Registration Number: NCT01420614
• Lead Sponsor: Policlinico Casilino ASL RMB

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

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 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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-07
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-19
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-05
• Last Update Posted: 2012-02-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1001

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radial	Radial approach	group of patients undergoing primary angioplasty by transradial approach
Femoral	Femoral approach	group of patients undergoing primary angioplasty by transfemoral approach

Primary Outcome Measures

Name	Time	Method
Net Adverse Clinical Event	30-day	Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Università di Modena e Reggio Emilia; 🇮🇹 Modena, Italy

Ospedale Sandro Pertini; 🇮🇹 Rome, Italy

Policlinico Casilino; 🇮🇹 Rome, Italy

University of Turin, San Giovanni Battista Hospital; 🇮🇹 Turin, Italy