Angioplasty Clinical Trial
Official title:
Research Evaluation to Study Individuals Who Show Thromboxane Or P2Y12 Receptor Resistance
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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