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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01136187
Other study ID # STEMI-RADIAL 16-9-2009
Secondary ID
Status Completed
Phase N/A
First received June 2, 2010
Last updated December 20, 2012
Start date October 2009
Est. completion date October 2012

Study information

Verified date December 2012
Source Charles University, Czech Republic
Contact n/a
Is FDA regulated No
Health authority Czech Republic: State Institute for Drug Control
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 707
Est. completion date October 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Access site in primary PCI


Locations

Country Name City State
Czech Republic University Hospital Hradec Kralove Hradec Kralove
Czech Republic Regional Hospital Liberec Liberec
Czech Republic University Hospital Pilsen Pilsen
Czech Republic Na Homolce Hospital Prague

Sponsors (5)

Lead Sponsor Collaborator
Charles University, Czech Republic Na Homolce Hospital, Regional Hospital Liberec, University Hospital Hradec Kralove, University Hospital Pilsen

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of bleeding or entry site complications 30 days
Secondary Occurence of major adverse cardiovascular events
Secondary Primary access site failure - conversion to another access
Secondary Angiographical procedural success
Secondary Contrast media consumption
Secondary Procedural and fluoroscopic times
Secondary Duration of hospital / ICU stay
Secondary TVR/TLR + any new hospitalization
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