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Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention (PCI)

NCT ID: NCT01136187

Last Updated: 2012-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

707 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-10-31

Brief Summary

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Percutaneous coronary interventions (PCIs) from the femoral approach have more bleeding complications related to access site in comparison to the radial approach in patients with acute coronary syndrome (ACS). Major bleeding and access site complications have an important role in results of PCI for ACS and lead to higher morbidity and mortality. Primary PCIs in ST elevation myocardial infarction (STEMI) are associated with more aggressive antithrombotic treatment than in elective or semi-urgent interventions. Currently, both radial and femoral approaches are routinely used for primary PCI in STEMI. However, only non-randomized studies and registries or small randomized single center studies comparing both approaches in primary PCI have been published until now. The aim of STEMI-RADIAL trial is to evaluate potential reduction of bleeding complications in the radial approach primary PCI compared to femoral approach in randomized, multicenter study.

Detailed Description

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Conditions

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ST Elevation Myocardial Infarction

Keywords

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Myocardial infarction Primary percutaneous coronary intervention Radial Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radial approach

Primary percutaneous coronary intervention from the radial approach

Group Type EXPERIMENTAL

Access site in primary PCI

Intervention Type PROCEDURE

Femoral approach

Primary percutaneous coronary intervention from the femoral approach

Group Type ACTIVE_COMPARATOR

Access site in primary PCI

Intervention Type PROCEDURE

Interventions

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Access site in primary PCI

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age over 18 years
* Admission for STEMI less than 12 hours after onset of symptoms

1. Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation ≥ 2 mm in two continuous precordial leads or ST elevations ≥ 1 mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI.
2. Patients are planned to be treated with primary PCI
* Ability to sign written informed consent

Exclusion Criteria

* Killip IV class or unconsciousness
* Patient disagreement
* Prior aortobifemoral bypass
* Absence of both radial or femoral artery pulsation
* Participation in another clinical trial randomizing ACS patients using antithrombotic drug.
* Negative Allen's test or Barbeau test type D
* Treatment with oral anticoagulants
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Pilsen

OTHER

Sponsor Role collaborator

Regional Hospital Liberec

OTHER

Sponsor Role collaborator

University Hospital Hradec Kralove

OTHER

Sponsor Role collaborator

Na Homolce Hospital

OTHER

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Ivo Bernat

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Hradec Kralove

Hradec Králové, , Czechia

Site Status

Regional Hospital Liberec

Liberec, , Czechia

Site Status

University Hospital Pilsen

Pilsen, , Czechia

Site Status

Na Homolce Hospital

Prague, , Czechia

Site Status

Countries

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Czechia

References

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Bernat I, Horak D, Stasek J, Mates M, Pesek J, Ostadal P, Hrabos V, Dusek J, Koza J, Sembera Z, Brtko M, Aschermann O, Smid M, Polansky P, Al Mawiri A, Vojacek J, Bis J, Costerousse O, Bertrand OF, Rokyta R. ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial: the STEMI-RADIAL trial. J Am Coll Cardiol. 2014 Mar 18;63(10):964-72. doi: 10.1016/j.jacc.2013.08.1651. Epub 2013 Nov 21.

Reference Type DERIVED
PMID: 24211309 (View on PubMed)

Other Identifiers

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STEMI-RADIAL 16-9-2009

Identifier Type: -

Identifier Source: org_study_id