Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE) - Full Text View

Sponsored by:	Momenta Pharmaceuticals, Inc.
Information provided by:	Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00543400

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease (CAD) Percutaneous Coronary Intervention (PCI)	Drug: M118 Drug: Unfractionated Heparin	Phase II

MedlinePlus related topics: Blood Thinners Coronary Artery Disease

Drug Information available for: Immunoglobulins Globulin, Immune Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment
Official Title:	A Randomized, Multi-Center, Open-Label, Parallel Group Feasibility Study to Determine the Safety and Efficacy of the Rationally Engineered Heparin M118 vs. Unfractionated Heparin (UFH) in Subjects With Stable Coronary Artery Disease Undergoing Percutaneous Coronary Intervention (PCI) And A Pharmacokinetic, Pharmacodynamic and Heparin Antibody Substudy

Further study details as provided by Momenta Pharmaceuticals, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	September 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Unfractionated Heparin Please see other invention description
2: Experimental	Drug: M118 75 IU/KG of M118, 100 IU/kg of M118 and 70 U/kg of unfractionated heparin given IV (in the vein) prior to Percutaneous Coronary Intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543400

Contacts

Contact: Mary E West

617-395-4943

mwest@momentapharma.com

Show 48 Study Locations

Sponsors and Collaborators

Momenta Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Sunil Rao, MD

Duke University

More Information

Responsible Party:	Momenta Pharmaceuticals, Inc. ( Mary E. West/Clinical Project Manager )
Study ID Numbers:	MOM-M118-006, M118-006a Substudy
Study First Received:	October 11, 2007
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00543400
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Heparin, Low-Molecular-Weight
Vascular Diseases
Ischemia
Arteriosclerosis

Calcium heparin
Coronary Disease
Antibodies
Heparin
Coronary Artery Disease
Immunoglobulins

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009