Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)
NCT ID: NCT00543400
Last Updated: 2019-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
503 participants
INTERVENTIONAL
2007-09-30
2009-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Unfractionated Heparin
IV infusion
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.
M118
intravenous (IV) infusion
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.
M118
intravenous (IV) infusion
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.
M118
intravenous (IV) infusion
Interventions
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M118
intravenous (IV) infusion
Unfractionated Heparin
IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Momenta Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sunil Rao, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Locations
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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
Allegheny Hospital
Pittsburgh, Pennsylvania, United States
Black Hills Clinical Research Center
Rapid City, South Dakota, United States
Centennial Heart Cardiovascular Consultants
Nashville, Tennessee, United States
Northwest Texas Healthcare System_Amarillo Heart Clinical Research Institute, Inc.
Amarillo, Texas, United States
Austin Heart, P.A.
Austin, Texas, United States
Plaza Medical Center of Fort Worth
Fort Worth, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Victoria Heart & Vascular Center
Victoria, Texas, United States
Providence Health Center
Waco, Texas, United States
UVA Cardiology, UVA Health System
Charlottesville, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Comprehensive Cardiology Care
Milwaukee, Wisconsin, United States
University of Alberta Hospital, WMC
Edmonton, Alberta, Canada
Vancouver General Hospital: Interventional Research
Vancouver, British Columbia, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Countries
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References
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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.
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.
Other Identifiers
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MOM-M118-006
Identifier Type: -
Identifier Source: org_study_id
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