Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

Completed · Phase 2

Conditions studied: Coronary Artery Disease (CAD)

In brief

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.

Key facts

Study ID

NCT00543400

Run by

Momenta Pharmaceuticals, Inc.

People needed

503

Starts

2007-09-01

Expected to finish

2009-05-01

Last updated by the study team

2019-10-15

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 19 years
• Ability to give informed consent
• Documented stable CAD with a significant lesion in a native coronary artery amenable to PCI with one stent
• Planned single vessel intervention

You may not qualify if…

• Myocardial infarction or unstable angina within the prior 7 days
• Target lesion is a chronic total occlusion (present for longer than 3 months)
• Target lesion with angiographically visible thrombus or in-stent thrombosis
• Target lesion is in a bypass graft
• Planned use of a GP IIb/IIIa inhibitor or planned use of atherectomy including directional, rotational, or laser
• Known allergies or sensitivities to heparin, pork, or pork-containing products
• History of HIT
• Hemodynamic instability
• Stroke or Transient Ischemic Attack (TIA) in the prior 3 months
• Active bleeding or bleeding diathesis
• Trauma or major surgery in the preceding month or planned surgery or PCI within the 30 days after the index PCI
• Suspected aortic dissection
• Receiving oral anticoagulation therapy
• Receipt of LMWH or of UFH (except for that used during the diagnostic portion of the index procedure) within the prior 7 days
• ACT > 200 prior to study drug administration
• Severe, untreated hypertension at the time of the index PCI procedure (systolic blood pressure of > 180 mm Hg, diastolic blood pressure > 90 mm Hg)
• Hemoglobin level of less than 10.0 g/dl or a hematocrit below 30%
• Platelet count of less than 100,000 per cubic millimeter or more than 600,000 per cubic millimeter
• Creatinine clearance < 30 mL/min
• Any malignancy within the prior 5 years with the exception of non-melanoma skin cancers
• Prior enrollment in EMINENCE trial or currently receiving other experimental therapy
• Pregnant or lactating if subject is female
• Substudy:
• Inclusion:
• Ability to give informed consent

Where it is running

• 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
• 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
• Trinity Medical Center — Rock Island, Illinois, United States
• Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
• University of Kentucky-Gill Heart Institute — Lexington, Kentucky, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Henry Ford Hospital Heart & Vascular Institute — Detroit, Michigan, United States
• Genesys Regional Medical Center — Grand Blanc, Michigan, United States
• Saint Mary's Duluth Clinic Health Center — Duluth, Minnesota, United States
• Minneapolis VA Medical Center — Minneapolis, Minnesota, United States
• Saint-Luke's Hospital / Mid America Heart Institute — Kansas City, Missouri, United States
• Saint Louis University Hospital — St Louis, Missouri, United States
• UNC Health Systems — Chapel Hill, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• Genesis Health Care System — Zanesville, Ohio, United States

Full record on ClinicalTrials.gov

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