Coronary Artery Disease (CAD) Clinical Trial
Official title:
A Randomized, Open-label, Parallel Group Feasibility Study to Determine the Safety and Efficacy of M118 vs. Unfractionated Heparin (UFH) in Subjects With Stable Coronary Artery Disease Undergoing Percutaneous Coronary Intervention (PCI)
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.
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