Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)
- Conditions
- Coronary Artery Disease (CAD)
- Interventions
- Drug: M118Drug: Unfractionated Heparin
- Registration Number
- NCT00543400
- Lead Sponsor
- Momenta Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 503
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 50 IU/KG of M118 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. 75 IU/KG of M118 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. 100 IU/KG of M118 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. 70 U/kg of unfractionated heparin given IV Unfractionated Heparin 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.
- Primary Outcome Measures
Name Time Method 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. 30 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
The Methodist Hospital
🇺🇸Houston, Texas, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Shands Jacksonville Medical Center (UFL)
🇺🇸Jacksonville, Florida, United States
University of Kentucky-Gill Heart Institute
🇺🇸Lexington, Kentucky, United States
Black Hills Clinical Research Center
🇺🇸Rapid City, South Dakota, United States
Vancouver General Hospital: Interventional Research
🇨🇦Vancouver, British Columbia, Canada
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Midwest Cardiovascular Research Foundation
🇺🇸Davenport, Iowa, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Minneapolis VA Medical Center
🇺🇸Minneapolis, Minnesota, United States
Centennial Heart Cardiovascular Consultants
🇺🇸Nashville, Tennessee, United States
Plaza Medical Center of Fort Worth
🇺🇸Fort Worth, Texas, United States
Comprehensive Cardiology Care
🇺🇸Milwaukee, Wisconsin, United States
Jim Moran Heart & Vascular Research Institute
🇺🇸Fort Lauderdale, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Allegheny Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Sciences Center
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Washington Hospital Center, Medstar Research Institute
🇺🇸Washington, District of Columbia, United States
Central Arkansas Veterans Healthcare System
🇺🇸Little Rock, Arkansas, United States
Suncoast Cardiovascular Research
🇺🇸Saint Petersburg, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Cardiology Research Associates
🇺🇸Ormond Beach, Florida, United States
Advocate Good Shephard Hospital
🇺🇸Barrington, Illinois, United States
Henry Ford Hospital Heart & Vascular Institute
🇺🇸Detroit, Michigan, United States
Trinity Medical Center
🇺🇸Rock Island, Illinois, United States
Saint-Luke's Hospital / Mid America Heart Institute
🇺🇸Kansas City, Missouri, United States
Saint Mary's Duluth Clinic Health Center
🇺🇸Duluth, Minnesota, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
UVA Cardiology, UVA Health System
🇺🇸Charlottesville, Virginia, United States
University of Alberta Hospital, WMC
🇨🇦Edmonton, Alberta, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Genesis Health Care System
🇺🇸Zanesville, Ohio, United States
Northwest Texas Healthcare System_Amarillo Heart Clinical Research Institute, Inc.
🇺🇸Amarillo, Texas, United States
Austin Heart, P.A.
🇺🇸Austin, Texas, United States
Saint Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
UNC Health Systems
🇺🇸Chapel Hill, North Carolina, United States
Victoria Heart & Vascular Center
🇺🇸Victoria, Texas, United States
Providence Health Center
🇺🇸Waco, Texas, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States