The primary objective is to evaluate the safety and feasibility of using M118 as an anticoagulant in the target population of subjects with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). The secondary objectives are to evaluate the effect of M118 on procedural indices including procedure success, abrupt closure, post-procedure TIMI flow, and catheter thrombus. Substudy Primary Objective The primary objective of the substudy is to characterize the pharmacokinetic and pharmacodynamic profile of M118 among subjects with stable coronary artery disease undergoing elective PCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
503
intravenous (IV) infusion
IV infusion
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States
Washington Hospital Center, Medstar Research Institute
Washington D.C., District of Columbia, United States
Jim Moran Heart & Vascular Research Institute
Fort Lauderdale, Florida, United States
Shands Jacksonville Medical Center (UFL)
Jacksonville, Florida, United States
Cardiology Research Associates
Ormond Beach, Florida, United States
Clinical Events Defined as the Composite of 30-day Death, MI, Repeat Revascularization, Catheter Thrombus, Stroke, Thrombocytopenia, Bailout Use of Glycoprotein IIb/IIIa Inhibitors and Bleeding.
Time frame: 30 days
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Suncoast Cardiovascular Research
St. Petersburg, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Advocate Good Shephard Hospital
Barrington, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
...and 34 more locations