Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111566
Status:
COMPLETED
Last Update Posted:
2013-11-28
First Post:
2005-05-23
Brief Title:
BRIEF-PCI Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention
Sponsor:
Cardiology Research UBC
Organization:
Cardiology Research UBC
Study Overview
Official Title:
Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2013-11
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:
This trial was designed to examine the efficacy of a brief versus a standard prolonged 18 hours infusion of eptifibatide in preventing troponin I release following successful coronary stenting
Detailed Description:
Percutaneous coronary intervention PCI is a common treatment for patients with severe ischemic heart disease In the majority of cases the potent anti-platelet agent eptifibatide is administered bolus followed by infusion for 18 hours The principal reason to use eptifibatide for PCI is to prevent platelet aggregation and the associated ischemia and myocardial infarction MI With improved laminar flow following stenting prolonged infusion of eptifibatide may no longer be necessary We hypothesize that after successful stenting with good angiographic results patients can have eptifibatide discontinued immediately without a higher risk of adverse ischemic outcome ie death MI or unplanned target vessel revascularization TVR by 30 days MI is defined as creatine kinase-MB CK-MB concentrations elevated to more than three times the upper limit of normal or new pathologic Q wave as seen on electrocardiograms ECG In order to prove this hypothesis we estimate a sample size of 2100 patients
Before embarking on a large-scale clinical trial we propose a pilot study using serum troponin I elevation as a surrogate end-point Troponin I is a sensitive biomarker of ischemic injury The absence of troponin I release following PCI would suggest excellent short and intermediate term prognosis For the pilot study we seek to prove the hypothesis that following successful PCI with stenting an abbreviated regimen of eptifibatide is not inferior to the standard infusion in preventing ischemic injury defined as troponin I release if baseline value is normal or as CK-MB more than 3 times upper limit of normal if baseline troponin I is elevated For this pilot study we estimate a sample size of 620 patients
Before embarking on a large-scale clinical trial we propose a pilot study using serum troponin I elevation as a surrogate end-point Troponin I is a sensitive biomarker of ischemic injury The absence of troponin I release following PCI would suggest excellent short and intermediate term prognosis For the pilot study we seek to prove the hypothesis that following successful PCI with stenting an abbreviated regimen of eptifibatide is not inferior to the standard infusion in preventing ischemic injury defined as troponin I release if baseline value is normal or as CK-MB more than 3 times upper limit of normal if baseline troponin I is elevated For this pilot study we estimate a sample size of 620 patients
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