At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating M118 and Unfractionated Heparin for Coronary Artery Disease (CAD). Completed, enrolled 503 participants across 44 sites in 2 countries.
Detailed Summary
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 Details
Timeline
Interventions
intravenous (IV) infusion
IV infusion