Randomized Study of Aspirin Resistant Patients Undergoing Angioplasty
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Research Evaluation to Study Individuals Who Show Thromboxane Or P2Y12 Receptor Resistance|
- 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.
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||December 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289601
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Daniel I Simon, MD||University Hospital Case Medical Center|