A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy
Phase 3
Completed
- Conditions
- Acute Coronary SyndromePercutaneous Coronary Intervention
- Registration Number
- NCT01014273
- Lead Sponsor
- Population Health Research Institute
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7021
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method First occurrence of the composite of death, MI, stroke or non CABG major bleeding (i.e. severe bleeding, other major bleeding) at 30 days. 30 days
- Secondary Outcome Measures
Name Time Method Non CABG major bleeding within 30 days following randomization Death, MI or stroke within 30 days following randomization
Trial Locations
- Locations (1)
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Hamilton Health Sciences🇨🇦Hamilton, Ontario, Canada