A Phase 3 interventional study of Percutaneous Coronary Intervention in Acute Coronary Syndrome and Percutaneous Coronary Intervention, sponsored by Population Health Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-07.
Sponsored by Population Health Research Institute · Phase 3, Interventional, and Treatment
This is a multi-national, multi-centre, randomized study comparing the trans-radial PCI access strategy and the trans-femoral PCI access strategy in ACS patients with UA or NSTEMI or STEMI planned to be treated with an invasive strategy (PCI).
The hypothesis is that radial access site PCI will be associated with significantly less major bleeding and access site complications compared with a femoral approach, without increasing the risk of ischemic events. The overall benefit-risk profile will favor a trans-radial approach.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 7,021 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Population Health Research Institute is the lead sponsor of 114 studies on the registry; 27 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
1.1 UA/NSTEMI patients
Ischemic symptoms suspected to represent a non-ST segment elevation ACS (unstable angina [UA] or non-ST segment elevation myocardial infarction NSTEMI) defined as:
Clinical history consistent with new onset, or a worsening pattern, of characteristic ischemic chest pain occurring at rest or with minimal exercise (lasting longer than 10 minutes) and planned to be managed with an invasive strategy
AND at least one of the following:
Electrocardiogram (ECG) changes compatible with new ischemia [ST depression of at least 1mm or transient ST elevation or ST elevation of less than or equal to 1 mm or T wave inversion greater than 2 mm in at least 2 contiguous leads].
or
Patients > 60 years of age with normal ECG are eligible provided there is a high degree of certainty that presenting symptoms are due to myocardial ischemia. Such patients must have documented evidence of previous coronary artery disease (CAD) with at least one of the following:
1.2 STEMI patients
Definite ECG changes compatible with STEMI: persistent ST-elevation (> 2 mm in two contiguous precordial leads or > 1 mm in at least two limb leads), or new left bundle branch block, or Q-wave in 2 contiguous leads
EXCLUSION CRITERIA
Femoral artery PCI access site
Procedure: Percutaneous Coronary Intervention
Radial artery PCI access site
Procedure: Percutaneous Coronary Intervention
First occurrence of the composite of death, MI, stroke or non CABG major bleeding (i.e. severe bleeding, other major bleeding) at 30 days.
Time frame: 30 days
Non CABG major bleeding
Time frame: within 30 days following randomization
Death, MI or stroke
Time frame: within 30 days following randomization
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Population Health Research Institute