RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome

NCT ID: NCT01420614

Last Updated: 2012-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1001 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-07-31

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.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; ST Elevation Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radial

group of patients undergoing primary angioplasty by transradial approach

Group Type: EXPERIMENTAL

Radial approach

Intervention Type: PROCEDURE

diagnostic and interventional procedures by radial artery access

Femoral

group of patients undergoing primary angioplasty by transfemoral approach

Group Type: ACTIVE_COMPARATOR

Femoral approach

Intervention Type: PROCEDURE

diagnostic and interventional procedures by femoral artery access

Interventions

Femoral approach

diagnostic and interventional procedures by femoral artery access

Intervention Type: PROCEDURE

Radial approach

diagnostic and interventional procedures by radial artery access

Intervention Type: PROCEDURE

Other Intervention Names

transfemoral; transradial

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Policlinico Casilino ASL RMB

OTHER

Sponsor Role: lead

Responsible Party

Enrico Romagnoli

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ernesto Lioy, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Casilino

Locations

Università di Modena e Reggio Emilia

Modena, Modena, Italy

Ospedale Sandro Pertini

Rome, Rome, Italy

Policlinico Casilino

Rome, Rome, Italy

University of Turin, San Giovanni Battista Hospital

Turin, Turin, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 22858390 (View on PubMed)

Other Identifiers

PC-03ER

Identifier Type: -

Identifier Source: org_study_id