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Coronary Artery Disease (CAD)Phase 2EMINENCENCT00543400

Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

A Phase 2 study testing M118 and Unfractionated Heparin in people with Coronary Artery Disease (CAD), run by Momenta Pharmaceuticals, Inc. at 44 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronary Artery Disease (CAD)
What is being tested?
M118 and Unfractionated Heparin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
503 participants
Where
44 sitesin 2 countries
Study dates
Sep 2007to May 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Ability to give informed consent
  • Participation in the main study protocol

Who cannot join

  • 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
Show all 24Show fewer
  • 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:
  • -Inability to provide the blood specimens required by the substudy protocol

Trial locations and contacts

44 sites in 2 countries.

44 sites in 2 countries

United States37 sites

  • Northwest Texas Healthcare System_Amarillo Heart Clinical Research Institute, Inc.

    Amarillo, Texas, 79106

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-5869

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Austin Heart, P.A.

    Austin, Texas, 78756

  • Advocate Good Shephard Hospital

    Barrington, Illinois, 60010

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • UNC Health Systems

    Chapel Hill, North Carolina, 27514

  • UVA Cardiology, UVA Health System

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Midwest Cardiovascular Research Foundation

    Davenport, Iowa, 52803

  • Henry Ford Hospital Heart & Vascular Institute

    Detroit, Michigan, 48202

  • Saint Mary's Duluth Clinic Health Center

    Duluth, Minnesota, 55805

  • Jim Moran Heart & Vascular Research Institute

    Fort Lauderdale, Florida, 33308

  • Plaza Medical Center of Fort Worth

    Fort Worth, Texas, 76104

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • The Methodist Hospital

    Houston, Texas, 77030

  • Shands Jacksonville Medical Center (UFL)

    Jacksonville, Florida, 32209

  • Saint-Luke's Hospital / Mid America Heart Institute

    Kansas City, Missouri, 64111

  • University of Kentucky-Gill Heart Institute

    Lexington, Kentucky, 40536

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas, 72205

  • Comprehensive Cardiology Care

    Milwaukee, Wisconsin, 53215

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • Centennial Heart Cardiovascular Consultants

    Nashville, Tennessee, 37203

  • Cardiology Research Associates

    Ormond Beach, Florida, 32174

  • Allegheny Hospital

    Pittsburgh, Pennsylvania, 15212

  • Black Hills Clinical Research Center

    Rapid City, South Dakota, 57701

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Trinity Medical Center

    Rock Island, Illinois, 61201

  • Saint Louis University Hospital

    St Louis, Missouri, 63110

  • Suncoast Cardiovascular Research

    St. Petersburg, Florida, 33701

  • Victoria Heart & Vascular Center

    Victoria, Texas, 77901

  • Providence Health Center

    Waco, Texas, 76712

  • Washington Hospital Center, Medstar Research Institute

    Washington D.C., District of Columbia, 20010

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157-1045

  • Genesis Health Care System

    Zanesville, Ohio, 43701

Other trials in United States

Canada7 sites

  • University of Alberta Hospital, WMC

    Edmonton, Alberta, T6G 2B7

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4WZ

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • St. Michael's Hospital

    Toronto, Ontario, T6G 2B7

  • Vancouver General Hospital: Interventional Research

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

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)

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.

Being tested
M118, Unfractionated Heparin
Keywords
Percutaneous Coronary Intervention (PCI)
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M118Drug

    intravenous (IV) infusion

  • Unfractionated HeparinDrug

    IV infusion

Study groups in NCT00543400
Study groupRoleWhat they receive
70 U/kg of unfractionated heparin given IVActive comparatorVenous 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.
Receives: Drug: Unfractionated Heparin
50 IU/KG of M118ExperimentalVenous 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.
Receives: Drug: M118
75 IU/KG of M118ExperimentalVenous 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.
Receives: Drug: M118
100 IU/KG of M118ExperimentalVenous 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.
Receives: Drug: M118

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionApr 2009
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
503 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00543400
Sponsor's protocol ID
MOM-M118-006
Acronym
EMINENCE
Status last verified
Jan 2018
First submitted
11 Oct 2007
Last updated
15 Oct 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19853689

  • 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.

    PubMed 20368520

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing M118 and Unfractionated Heparin in people with Coronary Artery Disease (CAD), run by Momenta Pharmaceuticals, Inc. at 44 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00543400, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.

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