Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

NCT00543400 | Completed Phase 2 Results DMC

• 1 other identifier: MOM-M118-006
• Study Type: interventional
• Target: 503
• Locations: 2 countries
• Sites: 44

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.

Conditions

Coronary Artery Disease (CAD)

Keywords

Percutaneous Coronary Intervention (PCI)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

70 U/kg of unfractionated heparin given IV

ACTIVE COMPARATOR

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.

Drug: Unfractionated Heparin

50 IU/KG of M118

EXPERIMENTAL

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.

Drug: M118

75 IU/KG of M118

EXPERIMENTAL

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.

Drug: M118

100 IU/KG of M118

EXPERIMENTAL

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.

Drug: M118

Interventions

M118 DRUG

intravenous (IV) infusion

100 IU/KG of M118; 50 IU/KG of M118; 75 IU/KG of M118

Unfractionated Heparin DRUG

IV infusion

70 U/kg of unfractionated heparin given IV

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Momenta Pharmaceuticals, Inc.: lead

Study Sites (44)

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72205, United States

Location

Washington Hospital Center, Medstar Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Jim Moran Heart & Vascular Research Institute

Fort Lauderdale, Florida, 33308, United States

Location

Shands Jacksonville Medical Center (UFL)

Jacksonville, Florida, 32209, United States

Location

Cardiology Research Associates

Ormond Beach, Florida, 32174, United States

Location

Suncoast Cardiovascular Research

St. Petersburg, Florida, 33701, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Advocate Good Shephard Hospital

Barrington, Illinois, 60010, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Trinity Medical Center

Rock Island, Illinois, 61201, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

University of Kentucky-Gill Heart Institute

Lexington, Kentucky, 40536, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109-5869, United States

Location

Henry Ford Hospital Heart & Vascular Institute

Detroit, Michigan, 48202, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Saint Mary's Duluth Clinic Health Center

Duluth, Minnesota, 55805, United States

Location

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Saint-Luke's Hospital / Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

UNC Health Systems

Chapel Hill, North Carolina, 27514, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157-1045, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Genesis Health Care System

Zanesville, Ohio, 43701, United States

Location

Allegheny Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Black Hills Clinical Research Center

Rapid City, South Dakota, 57701, United States

Location

Centennial Heart Cardiovascular Consultants

Nashville, Tennessee, 37203, United States

Location

Northwest Texas Healthcare System_Amarillo Heart Clinical Research Institute, Inc.

Amarillo, Texas, 79106, United States

Location

Austin Heart, P.A.

Austin, Texas, 78756, United States

Location

Plaza Medical Center of Fort Worth

Fort Worth, Texas, 76104, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Victoria Heart & Vascular Center

Victoria, Texas, 77901, United States

Location

Providence Health Center

Waco, Texas, 76712, United States

Location

UVA Cardiology, UVA Health System

Charlottesville, Virginia, 22908, United States

Location

McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Comprehensive Cardiology Care

Milwaukee, Wisconsin, 53215, United States

Location

University of Alberta Hospital, WMC

Edmonton, Alberta, T6G 2B7, Canada

Location

Vancouver General Hospital: Interventional Research

Vancouver, British Columbia, V5Z 1M9, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4WZ, Canada

Location

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

St. Michael's Hospital

Toronto, Ontario, T6G 2B7, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (2)

• 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.

  PMID: 19853689 BACKGROUND

• 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.

  PMID: 20368520 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

M-118 compound; Heparin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Jim Roach, MD Chief Medical Officer
• Organization: Momenta Pharmaceuticals

jroach@momentpharma.com

617-491-9700

Study Officials

• Sunil Rao, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2007
• First Posted: October 15, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 15, 2019
• Results First Posted: December 12, 2017

Record last verified: 2018-01

Locations

CA (7); US (37)