Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251823
Status:
COMPLETED
Last Update Posted:
2008-09-04
First Post:
2005-11-08
Brief Title:
Safety and Efficacy Study of Eptifibatide in Primary Percutaneous Coronary Intervention PCI
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
Official Title:
The Safety and Efficacy of Eptifibatide-Facilitated Percutaneous Coronary Angioplasty Versus Primary Percutaneous Coronary Angioplasty Alone
Status:
COMPLETED
Status Verified Date:
2008-09
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:
None
Brief Summary:
Rationale
ST-elevation myocardial infarction STEMI is usually triggered by rupture of an atherosclerotic plaque that then accumulates platelets and fibrin and leads to an occlusive coronary thrombus Clinical benefits obtained with revascularization of the infarct related artery IRA depend on the achievement of four goals
1 Early reperfusion
2 Full restoration of normal flow in the epicardial vessels
3 Full restoration of flow in the microcirculation and
4 Preservation of myocardial function
Reperfusion of the IRA can be achieved pharmacologically with intravenous thrombolytic agents or mechanically with percutaneous coronary intervention PCI In Canada thrombolysis is the current standard of care in most hospitals although there is mounting evidence that primary PCI is superior and many Canadian centres are shifting towards this strategy To offer primary PCI to community hospitals without on site cardiac catheterization facilities regional programs need to be present that allow rapid transfer to invasive centers that offer this procedure round-the-clock
Recent evidence suggests that angiographic and clinical results with primary PCI could be further enhanced by facilitation with a pharmacological treatment given prior to the procedure The present proposal plans to examine the safety and efficacy of eptifibatide to facilitate coronary angioplasty in STEMI in patients who present to centres with and without on-site catheterization facilities
The primary outcome measure will be a composite clinical endpoint including death recurrent myocardial infarction recurrent unstable ischemia or stroke at 30 days
Secondary endpoints include the percent thrombolysis in myocardial infarction TIMI grade 3 coronary flow after the PCI myocardial perfusion score individual clinical outcomes as listed for the primary endpoint resolution of ST-segment elevation requirement for subsequent revascularization frequency of congestive heart failure CHF cardiogenic shock and Canadian Cardiovascular Society CCS angina class
ST-elevation myocardial infarction STEMI is usually triggered by rupture of an atherosclerotic plaque that then accumulates platelets and fibrin and leads to an occlusive coronary thrombus Clinical benefits obtained with revascularization of the infarct related artery IRA depend on the achievement of four goals
1 Early reperfusion
2 Full restoration of normal flow in the epicardial vessels
3 Full restoration of flow in the microcirculation and
4 Preservation of myocardial function
Reperfusion of the IRA can be achieved pharmacologically with intravenous thrombolytic agents or mechanically with percutaneous coronary intervention PCI In Canada thrombolysis is the current standard of care in most hospitals although there is mounting evidence that primary PCI is superior and many Canadian centres are shifting towards this strategy To offer primary PCI to community hospitals without on site cardiac catheterization facilities regional programs need to be present that allow rapid transfer to invasive centers that offer this procedure round-the-clock
Recent evidence suggests that angiographic and clinical results with primary PCI could be further enhanced by facilitation with a pharmacological treatment given prior to the procedure The present proposal plans to examine the safety and efficacy of eptifibatide to facilitate coronary angioplasty in STEMI in patients who present to centres with and without on-site catheterization facilities
The primary outcome measure will be a composite clinical endpoint including death recurrent myocardial infarction recurrent unstable ischemia or stroke at 30 days
Secondary endpoints include the percent thrombolysis in myocardial infarction TIMI grade 3 coronary flow after the PCI myocardial perfusion score individual clinical outcomes as listed for the primary endpoint resolution of ST-segment elevation requirement for subsequent revascularization frequency of congestive heart failure CHF cardiogenic shock and Canadian Cardiovascular Society CCS angina class
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