NCT00543400

Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 503 (actual)
• Sponsor: Momenta Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease (CAD)

Interventions

Type	Name	Description
DRUG	M118	intravenous (IV) infusion
DRUG	Unfractionated Heparin	IV infusion

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2007-10-15
• Last updated: 2019-10-15
• Results posted: 2017-12-12

Locations

44 sites across 2 countries: United States, Canada