Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00543400
First received: October 11, 2007
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease (CAD)
Percutaneous Coronary Intervention (PCI)
Drug: M118
Drug: Unfractionated Heparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized, Multi-center, Open-label, Parallel Group Feasibility Study to Determine the Safety and Efficacy of the Rationally Engineered Heparin M118 vs. Unfractionated Heparin (UFH) in Subjects With Stable Coronary Artery Disease Undergoing Percutaneous Coronary Intervention (PCI) And A Pharmacokinetic, Pharmacodynamic and Heparin Antibody Substudy

Resource links provided by NLM:


Further study details as provided by Momenta Pharmaceuticals, Inc.:

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. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 503
Study Start Date: September 2007
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Unfractionated Heparin
Please see other invention description
Experimental: 2 Drug: M118
75 IU/KG of M118, 100 IU/kg of M118 and 70 U/kg of unfractionated heparin given IV (in the vein) prior to Percutaneous Coronary Intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543400

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

No publications provided by Momenta Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00543400     History of Changes
Other Study ID Numbers: MOM-M118-006, M118-006a Substudy
Study First Received: October 11, 2007
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 27, 2014