Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

Momenta Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease (CAD)

Treatments: Drug: Unfractionated Heparin; Drug: M118

Study type: Interventional

Funder types: Industry

Identifiers

NCT00543400

MOM-M118-006

Details and patient eligibility

About

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.

Enrollment: 503 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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503 participants in 4 patient groups

70 U/kg of unfractionated heparin given IV

Active Comparator group

Description:

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.

Treatment:

Drug: Unfractionated Heparin

50 IU/KG of M118

Experimental group

Description:

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.

Treatment:

Drug: M118

75 IU/KG of M118

Experimental group

Description:

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.

Treatment:

Drug: M118

100 IU/KG of M118

Experimental group

Description:

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.

Treatment:

Drug: M118