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Sponsored by: |
Momenta Pharmaceuticals, Inc. |
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Information provided by: | Momenta Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00543400 |
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 |
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Coronary Artery Disease (CAD) Percutaneous Coronary Intervention (PCI) |
Drug: M118 Drug: Unfractionated Heparin |
Phase II |
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 |
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 |
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1: Active Comparator |
Drug: Unfractionated Heparin
Please see other invention description
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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.
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Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Substudy:
Inclusion:
Exclusion:
-Inability to provide the blood specimens required by the substudy protocol
Contact: Mary E West | 617-395-4943 | mwest@momentapharma.com |
Principal Investigator: | Sunil Rao, MD | Duke University |
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 |
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 |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |