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

Policlinico Casilino ASL RMB

Status: Unknown

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

Treatments: Procedure: Radial approach; Procedure: Femoral approach

Study type: Interventional

Funder types: Other

Identifiers

NCT01420614

PC-03ER

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,001 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,001 participants in 2 patient groups

Radial

Experimental group

Description:

group of patients undergoing primary angioplasty by transradial approach

Treatment:

Procedure: Radial approach

Femoral

Active Comparator group

Description:

group of patients undergoing primary angioplasty by transfemoral approach

Treatment:

Procedure: Femoral approach