Clinical trial NCT00543400: Evaluation of M118 in Percutaneous Coronary Intervention (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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease (CAD)
Keywords: Percutaneous Coronary Intervention (PCI)
Lead sponsor: Momenta Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 503
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
city: Washington
country: United States
facility: Washington Hospital Center, Medstar Research Institute
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Jim Moran Heart & Vascular Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Shands Jacksonville Medical Center (UFL)
state: Florida
city: Ormond Beach
country: United States
facility: Cardiology Research Associates
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Cardiovascular Research
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Barrington
country: United States
facility: Advocate Good Shephard Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Rock Island
country: United States
facility: Trinity Medical Center
state: Illinois
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky-Gill Heart Institute
state: Kentucky
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital Heart & Vascular Institute
state: Michigan
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Duluth
country: United States
facility: Saint Mary's Duluth Clinic Health Center
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
city: Kansas City
country: United States
facility: Saint-Luke's Hospital / Mid America Heart Institute
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
city: Chapel Hill
country: United States
facility: UNC Health Systems
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Zanesville
country: United States
facility: Genesis Health Care System
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny Hospital
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Clinical Research Center
state: South Dakota
city: Nashville
country: United States
facility: Centennial Heart Cardiovascular Consultants
state: Tennessee
city: Amarillo
country: United States
facility: Northwest Texas Healthcare System_Amarillo Heart Clinical Research Institute, Inc.
state: Texas
city: Austin
country: United States
facility: Austin Heart, P.A.
state: Texas
city: Fort Worth
country: United States
facility: Plaza Medical Center of Fort Worth
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Victoria
country: United States
facility: Victoria Heart & Vascular Center
state: Texas
city: Waco
country: United States
facility: Providence Health Center
state: Texas
city: Charlottesville
country: United States
facility: UVA Cardiology, UVA Health System
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Milwaukee
country: United States
facility: Comprehensive Cardiology Care
state: Wisconsin
city: Edmonton
country: Canada
facility: University of Alberta Hospital, WMC
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital: Interventional Research
state: British Columbia
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Duke Clinical Research Institute
name: Sunil Rao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.