RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome

Coronary Artery Disease Clinical Trial

— RIFLE-STEACS  

Official title:

RadIal Versus Femoral Randomized InvEstigation in ST Elevation Acute Coronary Syndrome

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01420614
• Other study ID #: PC-03ER
• Status: Unknown status
• Phase: N/A
• First received: August 15, 2011
• Last updated: February 5, 2012
• Start date: January 2009
• Est. completion date: July 2012

Study information

• Verified date: February 2012
• Source: Policlinico Casilino ASL RMB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 1001
• Est. completion date: July 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• ST Elevation Acute Myocardial Infarction
• Syndrome

Intervention

Procedure:
• Femoral approach
diagnostic and interventional procedures by femoral artery access
• Radial approach
diagnostic and interventional procedures by radial artery access

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Casilino ASL RMB

Country where clinical trial is conducted

Italy, 

Outcome

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