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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,200
Brigham and Women's Hospital
Boston, Massachusetts, United States
The primary endpoint is the incidence of myonecrosis, defined as an elevation in creatinine kinase - myocardial band (CK-MB) > 2 x IU/ml above the institution's upper limit of normal within 24 hours following low-medium risk PCI.
Incidence of CK-MB elevation >3x ULN
Incidence of CK-MB elevation to 3-5x ULN
Incidence of CK-MB elevation >5x ULN
Incidence of troponin I > 0.1ng/ml
MACE rates reported at discharge, 30 days and 6 months. (MACE is defined as a composite endpoint of death, MI, ischemic (non-hemorrhagic) stroke, and urgent target vessel revascularization)
Rate of bail-out use of eptifibatide/placebo.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.