NCT01420614

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,001

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

2.5 years

First QC Date

August 15, 2011

Last Update Submit

February 5, 2012

Conditions

Coronary Artery DiseaseAcute Coronary SyndromeST Elevation Acute Myocardial Infarction

Keywords

radial accessprimary angioplastytrialrandomizationoutcome

Outcome Measures

Primary Outcomes (1)

  • Net Adverse Clinical Event

    Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding

    30-day

Secondary Outcomes (5)

  • Net Adverse Clinical Event

    1-year

  • Individual components of NACE

    30-day

  • Individual components of NACE

    1-year

  • Total procedural and fluoroscopy times for the index procedure

    1 day

  • Hospital stay

    30-day

Study Arms (2)

Radial

EXPERIMENTAL

group of patients undergoing primary angioplasty by transradial approach

Procedure: Radial approach

Femoral

ACTIVE COMPARATOR

group of patients undergoing primary angioplasty by transfemoral approach

Procedure: Femoral approach

Interventions

Femoral approachPROCEDURE

diagnostic and interventional procedures by femoral artery access

Also known as: transfemoral
Femoral
Radial approachPROCEDURE

diagnostic and interventional procedures by radial artery access

Also known as: transradial
Radial

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.
  • Prior participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Università di Modena e Reggio Emilia

Modena, Modena, 41124, Italy

Location

Ospedale Sandro Pertini

Rome, Rome, 00100, Italy

Location

Policlinico Casilino

Rome, Rome, 00100, Italy

Location

University of Turin, San Giovanni Battista Hospital

Turin, Turin, 10100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 22858390DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ernesto Lioy, MD

    Policlinico Casilino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 15, 2011

First Posted

August 19, 2011

Study Start

January 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2012

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations

IT(4)