Back to resultsRadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome (RIFLE-STEACS)
Primary Purpose
Coronary Artery Disease, Acute Coronary Syndrome, ST Elevation Acute Myocardial Infarction
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Femoral approach
Radial approach
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring radial access, primary angioplasty, trial, randomization, outcome
Eligibility Criteria
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.
Sites / Locations
- Università di Modena e Reggio Emilia
- Ospedale Sandro Pertini
- Policlinico Casilino
- University of Turin, San Giovanni Battista Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Radial
Femoral
Arm Description
group of patients undergoing primary angioplasty by transradial approach
group of patients undergoing primary angioplasty by transfemoral approach
Outcomes
Primary Outcome Measures
Net Adverse Clinical Event
Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding
Secondary Outcome Measures
Net Adverse Clinical Event
Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding
Individual components of NACE
Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding
Individual components of NACE
Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding
Total procedural and fluoroscopy times for the index procedure
Comparison of procedural and fluoroscopy times between the two study groups
Hospital stay
Days of hospitalization
Full Information
NCT ID
NCT01420614
First Posted
August 15, 2011
Last Updated
February 5, 2012
Sponsor
Policlinico Casilino ASL RMB
1. Study Identification
Unique Protocol Identification Number
NCT01420614
Brief Title
RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome
Acronym
RIFLE-STEACS
Official Title
RadIal Versus Femoral Randomized InvEstigation in ST Elevation Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Casilino ASL RMB
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Acute Coronary Syndrome, ST Elevation Acute Myocardial Infarction
Keywords
radial access, primary angioplasty, trial, randomization, outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1001 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radial
Arm Type
Experimental
Arm Description
group of patients undergoing primary angioplasty by transradial approach
Arm Title
Femoral
Arm Type
Active Comparator
Arm Description
group of patients undergoing primary angioplasty by transfemoral approach
Intervention Type
Procedure
Intervention Name(s)
Femoral approach
Other Intervention Name(s)
transfemoral
Intervention Description
diagnostic and interventional procedures by femoral artery access
Intervention Type
Procedure
Intervention Name(s)
Radial approach
Other Intervention Name(s)
transradial
Intervention Description
diagnostic and interventional procedures by radial artery access
Primary Outcome Measure Information:
Title
Net Adverse Clinical Event
Description
Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding
Time Frame
30-day
Secondary Outcome Measure Information:
Title
Net Adverse Clinical Event
Description
Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding
Time Frame
1-year
Title
Individual components of NACE
Description
Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding
Time Frame
30-day
Title
Individual components of NACE
Description
Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding
Time Frame
1-year
Title
Total procedural and fluoroscopy times for the index procedure
Description
Comparison of procedural and fluoroscopy times between the two study groups
Time Frame
1 day
Title
Hospital stay
Description
Days of hospitalization
Time Frame
30-day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernesto Lioy, MD
Organizational Affiliation
Policlinico Casilino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Università di Modena e Reggio Emilia
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Ospedale Sandro Pertini
City
Rome
ZIP/Postal Code
00100
Country
Italy
Facility Name
Policlinico Casilino
City
Rome
ZIP/Postal Code
00100
Country
Italy
Facility Name
University of Turin, San Giovanni Battista Hospital
City
Turin
ZIP/Postal Code
10100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22858390
Citation
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.
Results Reference
derived
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RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome
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