RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome (RIFLE-STEACS)

RadIal Versus Femoral Randomized InvEstigation in ST Elevation Acute Coronary Syndrome

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

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome; ST Elevation Acute Myocardial Infarction
• Intervention / Treatment: Procedure: Radial approach; Procedure: Femoral approach

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 Type: Interventional
• Enrollment (Actual): 1001
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy, 41124
    • Università di Modena e Reggio Emilia
  • Rome, Italy, 00100
    • Ospedale Sandro Pertini
  • Rome, Italy, 00100
    • Policlinico Casilino
  • Turin, Italy, 10100
    • University of Turin, San Giovanni Battista Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Policlinico Casilino ASL RMB
• Investigators: Principal Investigator: Ernesto Lioy, MD, Policlinico Casilino

Publications and helpful links

General Publications

• Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2481-9. doi: 10.1016/j.jacc.2012.06.017. Epub 2012 Aug 1.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: August 15, 2011
• First Submitted That Met QC Criteria: August 18, 2011
• First Posted (Estimate): August 19, 2011

Study Record Updates

• Last Update Posted (Estimate): February 7, 2012
• Last Update Submitted That Met QC Criteria: February 5, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: outcome; trial; randomization; primary angioplasty; radial access
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: PC-03ER