Ignite Creation Date:
2024-05-05 @ 11:41 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01398254
Status:
COMPLETED
Last Update Posted:
2019-01-29
First Post:
2011-07-13
Brief Title:
Femoral Versus Radial Access for Primary PCI
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
Official Title:
The Safety and Efficacy of Femoral Access Versus Radial for Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction SAFARI-STEMI Trial
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFARI-STEMI
Brief Summary:
Primary percutaneous coronary intervention PPCI has become the dominant strategy for the treatment of ST-elevation myocardial infarction STEMI as studies have shown that PPCI is superior to fibrinolytic therapy Recent evidence suggests that transradial access TRA is superior to transfemoral TFA for patients undergoing PPCI Two large trials report a mortality benefit favouring TRA The results of these two trials could significantly impact practice guidelines and lead to a recommendation that the approach of choice for primary PCI be radial rather than femoral This would have significant implications for both PCI centers and interventionalists associated with a large impact on practice and education Yet many centers and interventionalists in Canada and in the USA prefer TFA and currently feel pressured in making the change to TRA With that said these trials did not include new pharmacotherapy and new technology that would likely have closed or eliminated the gap between TFA and TRA by improving the safety and efficacy of these two approaches Furthermore these trials were not powered to conclusively show a mortality benefit The authors of the two large trials emphasized the need for further trials to confirm the benefits of TRA
The SAFARI-STEMI trial aims to compare TFA with TRA in patients undergoing primary percutaneous intervention PPCI The primary outcome will be defined as all cause mortality measured at 30 days The trial will also evaluate 1 bleeding events and 2 the composite of death reinfarction or stroke defined as major adverse clinical events MACE The trial will include the use of antithrombotic therapy with monotherapy with either bivalirudin or unfractionated heparin the use of glycoprotein inhibitors IIbIIIa inhibitors will be avoided The study will encourage liberal use of vascular closing devices The trial will also compare delays to reperfusion between the two strategies Finally a cost analysis is proposed
In view of recent publications there is now a need for a large randomized trial using contemporary adjunct therapies to assess the safety and efficacy of the TRA vs the TFA in PPCI The proposed trial aims to conclusively show whether there is a survival benefit associated with the TRA approach
The SAFARI-STEMI trial aims to compare TFA with TRA in patients undergoing primary percutaneous intervention PPCI The primary outcome will be defined as all cause mortality measured at 30 days The trial will also evaluate 1 bleeding events and 2 the composite of death reinfarction or stroke defined as major adverse clinical events MACE The trial will include the use of antithrombotic therapy with monotherapy with either bivalirudin or unfractionated heparin the use of glycoprotein inhibitors IIbIIIa inhibitors will be avoided The study will encourage liberal use of vascular closing devices The trial will also compare delays to reperfusion between the two strategies Finally a cost analysis is proposed
In view of recent publications there is now a need for a large randomized trial using contemporary adjunct therapies to assess the safety and efficacy of the TRA vs the TFA in PPCI The proposed trial aims to conclusively show whether there is a survival benefit associated with the TRA approach
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011311-01H | None | None | None |