Clinical trial NCT01420614: RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome
Official title: RadIal Versus Femoral Randomized InvEstigation in ST Elevation Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
ST Elevation Acute Myocardial Infarction
Keywords: radial access
primary angioplasty
trial
randomization
outcome
Lead sponsor: Policlinico Casilino ASL RMB
Sponsor class: OTHER
First posted: 2011-08-19
Enrollment: 1001
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Net Adverse Clinical Event
timeFrame: 30-day
Secondary outcomes:
measure: Net Adverse Clinical Event
timeFrame: 1-year
measure: Individual components of NACE
timeFrame: 30-day
measure: Individual components of NACE
timeFrame: 1-year
measure: Total procedural and fluoroscopy times for the index procedure
timeFrame: 1 day
measure: Hospital stay
timeFrame: 30-day
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Università di Modena e Reggio Emilia
city: Rome
country: Italy
facility: Ospedale Sandro Pertini
city: Rome
country: Italy
facility: Policlinico Casilino
city: Turin
country: Italy
facility: University of Turin, San Giovanni Battista Hospital
Study officials:
affiliation: Policlinico Casilino
name: Ernesto Lioy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.