Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00289601
Status:
TERMINATED
Last Update Posted:
2007-07-20
First Post:
2006-02-08
Brief Title:
Randomized Study of Aspirin Resistant Patients Undergoing Angioplasty
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Research Evaluation to Study Individuals Who Show Thromboxane Or P2Y12 Receptor Resistance
Status:
TERMINATED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor support withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized double-blind multi-center study designed to compare differences in rates of myonecrosis measured as an elevation of CK-MB ratio 2 times ULN within 24 hours following low-medium risk percutaneous coronary intervention PCI in aspirin or clopidogrel non-responsive patients who are randomized to heparin with or without eptifibatide therapy during PCI The primary objective of this study is to determine if the use of eptifibatide is associated with a significant difference in post-PCI myonecrosis measured as an elevation of CK-MB ratio 2 times upper limit of normal ULN within 24 hours of low-medium risk PCI in patients who are aspirin or non-responsive as determined by VerifyNow Aspirin and P2Y12 testing
Detailed Description:
The primary objective of this study is to determine if the use of eptifibatide is associated with a significant difference in post-PCI myonecrosis measured as an elevation of CK-MB ratio 2 times upper limit of normal ULN within 24 hours of low-medium risk PCI in patients who are aspirin or clopidogrel non-responsive as determined by VerifyNow Aspirin and P2Y12 testing
Secondary study objectives will include an assessment of safety These safety determinations will be determined by monitoring the rates of MACE defined as death MI ischemic non-hemorrhagic stroke and urgent revascularization by repeat PCI or CABG bleeding events rate of bailout procedures performed elevations of CK-MB ratio in the range of 3 to 5 times ULN and greater than 5 times ULN and elevations of troponin I
This study is a randomized double-blind multi-center study designed to compare differences in rates of myonecrosis measured as an elevation of CK-MB ratio 2 times ULN within 24 hours following low-medium risk percutaneous coronary intervention PCI in aspirin or clopidogrel non-responsive patients who are randomized to heparin with or without eptifibatide therapy during PCI All subjects must also be pretreated with clopidogrel 300-600 mg at least 2 hours before PCI Study subjects will be randomized to either eptifibatide and unfractionated heparin or unfractionated heparin and placebo Study subject randomization in aspirin non-responsive patients will be stratified based upon clopidogrel responsiveness
Secondary study objectives will include an assessment of safety These safety determinations will be determined by monitoring the rates of MACE defined as death MI ischemic non-hemorrhagic stroke and urgent revascularization by repeat PCI or CABG bleeding events rate of bailout procedures performed elevations of CK-MB ratio in the range of 3 to 5 times ULN and greater than 5 times ULN and elevations of troponin I
This study is a randomized double-blind multi-center study designed to compare differences in rates of myonecrosis measured as an elevation of CK-MB ratio 2 times ULN within 24 hours following low-medium risk percutaneous coronary intervention PCI in aspirin or clopidogrel non-responsive patients who are randomized to heparin with or without eptifibatide therapy during PCI All subjects must also be pretreated with clopidogrel 300-600 mg at least 2 hours before PCI Study subjects will be randomized to either eptifibatide and unfractionated heparin or unfractionated heparin and placebo Study subject randomization in aspirin non-responsive patients will be stratified based upon clopidogrel responsiveness
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