Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE) (EMINENCE)

October 11, 2019 updated by: Momenta Pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

503

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital, WMC
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital: Interventional Research
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4WZ
        • University of Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Center
      • Toronto, Ontario, Canada, T6G 2B7
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Central Arkansas Veterans Healthcare System
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center, Medstar Research Institute
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Jim Moran Heart & Vascular Research Institute
      • Jacksonville, Florida, United States, 32209
        • Shands Jacksonville Medical Center (UFL)
      • Ormond Beach, Florida, United States, 32174
        • Cardiology Research Associates
      • Saint Petersburg, Florida, United States, 33701
        • Suncoast Cardiovascular Research
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Illinois
      • Barrington, Illinois, United States, 60010
        • Advocate Good Shephard Hospital
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Rock Island, Illinois, United States, 61201
        • Trinity Medical Center
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Midwest Cardiovascular Research Foundation
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky-Gill Heart Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5869
        • University of Michigan Health System
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital Heart & Vascular Institute
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Saint Mary's Duluth Clinic Health Center
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint-Luke's Hospital / Mid America Heart Institute
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Health Systems
      • Winston-Salem, North Carolina, United States, 27157-1045
        • Wake Forest University Health Sciences
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Zanesville, Ohio, United States, 43701
        • Genesis Health Care System
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Hospital
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Clinical Research Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Centennial Heart Cardiovascular Consultants
    • Texas
      • Amarillo, Texas, United States, 79106
        • Northwest Texas Healthcare System_Amarillo Heart Clinical Research Institute, Inc.
      • Austin, Texas, United States, 78756
        • Austin Heart, P.A.
      • Fort Worth, Texas, United States, 76104
        • Plaza Medical Center of Fort Worth
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Victoria, Texas, United States, 77901
        • Victoria Heart & Vascular Center
      • Waco, Texas, United States, 76712
        • Providence Health Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • UVA Cardiology, UVA Health System
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Comprehensive Cardiology Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Participation in the main study protocol

Exclusion:

-Inability to provide the blood specimens required by the substudy protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 70 U/kg of unfractionated heparin given IV
Venous injection (IV) of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
Drug: Unfractionated Heparin
IV infusion
Experimental: 50 IU/KG of M118
Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
Drug: M118
intravenous (IV) infusion
Experimental: 75 IU/KG of M118
Venous injection of 75 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
Drug: M118
intravenous (IV) infusion
Experimental: 100 IU/KG of M118
Venous injection of 100 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
Drug: M118
intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Momenta Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Sunil Rao, MD, Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

October 11, 2007

First Submitted That Met QC Criteria

October 12, 2007

First Posted (Estimate)

October 15, 2007

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOM-M118-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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