Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

Coronary Artery Disease (CAD) Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543400
• Other study ID #: MOM-M118-006
• Status: Completed
• Phase: Phase 2
• Start date: September 2007
• Est. completion date: May 2009

Study information

• Verified date: January 2018
• Source: Momenta Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• M118
intravenous (IV) infusion
• Unfractionated Heparin
IV infusion

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Momenta Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & 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. — View Citation

Rao SV, Melloni C, Myles-Dimauro S, Broderick S, Kosinski AS, Kleiman NS, Dzavík 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 int — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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