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

Primary Purpose

Coronary Artery Disease (CAD)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
M118
Unfractionated Heparin
Sponsored by
Momenta Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease (CAD) focused on measuring Percutaneous Coronary Intervention (PCI)

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Arkansas Veterans Healthcare System
  • Washington Hospital Center, Medstar Research Institute
  • Jim Moran Heart & Vascular Research Institute
  • Shands Jacksonville Medical Center (UFL)
  • Cardiology Research Associates
  • Suncoast Cardiovascular Research
  • Emory University Hospital
  • Advocate Good Shephard Hospital
  • Rush University Medical Center
  • University of Chicago
  • Trinity Medical Center
  • Midwest Cardiovascular Research Foundation
  • University of Kentucky-Gill Heart Institute
  • Beth Israel Deaconess Medical Center
  • University of Michigan Health System
  • Henry Ford Hospital Heart & Vascular Institute
  • Genesys Regional Medical Center
  • Saint Mary's Duluth Clinic Health Center
  • Minneapolis VA Medical Center
  • Saint-Luke's Hospital / Mid America Heart Institute
  • Saint Louis University Hospital
  • UNC Health Systems
  • Wake Forest University Health Sciences
  • Riverside Methodist Hospital
  • Genesis Health Care System
  • Allegheny Hospital
  • Black Hills Clinical Research Center
  • Centennial Heart Cardiovascular Consultants
  • Northwest Texas Healthcare System_Amarillo Heart Clinical Research Institute, Inc.
  • Austin Heart, P.A.
  • Plaza Medical Center of Fort Worth
  • The Methodist Hospital
  • Victoria Heart & Vascular Center
  • Providence Health Center
  • UVA Cardiology, UVA Health System
  • McGuire VA Medical Center
  • Comprehensive Cardiology Care
  • University of Alberta Hospital, WMC
  • Vancouver General Hospital: Interventional Research
  • University of Ottawa Heart Institute
  • Sunnybrook Health Sciences Center
  • Toronto General Hospital
  • St. Michael's Hospital
  • Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

70 U/kg of unfractionated heparin given IV

50 IU/KG of M118

75 IU/KG of M118

100 IU/KG of M118

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2007
Last Updated
October 11, 2019
Sponsor
Momenta Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00543400
Brief Title
Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)
Acronym
EMINENCE
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Momenta Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD)
Keywords
Percutaneous Coronary Intervention (PCI)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
503 (Actual)

8. Arms, Groups, and Interventions

Arm Title
70 U/kg of unfractionated heparin given IV
Arm Type
Active Comparator
Arm Description
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.
Arm Title
50 IU/KG of M118
Arm Type
Experimental
Arm Description
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.
Arm Title
75 IU/KG of M118
Arm Type
Experimental
Arm Description
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.
Arm Title
100 IU/KG of M118
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
M118
Intervention Description
intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Unfractionated Heparin
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Rao, MD
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Washington Hospital Center, Medstar Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Jim Moran Heart & Vascular Research Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Shands Jacksonville Medical Center (UFL)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Cardiology Research Associates
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Suncoast Cardiovascular Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Advocate Good Shephard Hospital
City
Barrington
State/Province
Illinois
ZIP/Postal Code
60010
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Trinity Medical Center
City
Rock Island
State/Province
Illinois
ZIP/Postal Code
61201
Country
United States
Facility Name
Midwest Cardiovascular Research Foundation
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
University of Kentucky-Gill Heart Institute
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5869
Country
United States
Facility Name
Henry Ford Hospital Heart & Vascular Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Saint Mary's Duluth Clinic Health Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Minneapolis VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Saint-Luke's Hospital / Mid America Heart Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Saint Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
UNC Health Systems
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1045
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Genesis Health Care System
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Allegheny Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Black Hills Clinical Research Center
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Centennial Heart Cardiovascular Consultants
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Northwest Texas Healthcare System_Amarillo Heart Clinical Research Institute, Inc.
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Austin Heart, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Plaza Medical Center of Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Victoria Heart & Vascular Center
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Facility Name
Providence Health Center
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
UVA Cardiology, UVA Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Comprehensive Cardiology Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
University of Alberta Hospital, WMC
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Vancouver General Hospital: Interventional Research
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4WZ
Country
Canada
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19853689
Citation
Melloni C, Fier I, Roach J, Kosinski AS, Broderick S, Sigmon K, Myles S, Becker RC, Rao SV; EMINENCE Investigators. Design and rationale of the Evaluation of M118 IN pErcutaNeous Coronary intErvention (EMINENCE) trial. Am Heart J. 2009 Nov;158(5):726-33. doi: 10.1016/j.ahj.2009.08.020. Epub 2009 Sep 30.
Results Reference
background
PubMed Identifier
20368520
Citation
Rao SV, Melloni C, Myles-Dimauro S, Broderick S, Kosinski AS, Kleiman NS, Dzavik V, Tanguay JF, Chandna H, Gammon R, Rivera E, Alexander JH, Fier I, Roach J, Becker RC; EMINENCE Investigators. Evaluation of a new heparin agent in percutaneous coronary intervention: results of the phase 2 evaluation of M118 IN pErcutaNeous Coronary intErvention (EMINENCE) Trial. Circulation. 2010 Apr 20;121(15):1713-21. doi: 10.1161/CIRCULATIONAHA.109.913277. Epub 2010 Apr 5.
Results Reference
result

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Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

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