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Sponsors and Collaborators: |
Sanofi-Aventis Organon Duke University University of Chicago |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00139815 |
Study Objectives
PRIMARY OBJECTIVE: To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death, myocardial infarction or refactory ischemia up to Day 9 in the acute treatment of patients with unstable angina/non ST-segment elevation myocardial infarction concurrently managed with standard medical therapy.
SECONDARY OBJECTIVE: If non inferiority of fondaparinux is established on initial statistical analysis in a second step, superiority of fondaparinux to enoxaparin will be evaluated statistically.
Study Drug: Patients will be randomized to receive either:
Duration of Therapy:
Substudy:
Primary Outcome: The first occurence of any component of the following composite up to Day 9:
Condition | Intervention | Phase |
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Unstable Angina or Non ST-Segment Elevation Myocardial Infarction |
Drug: Fondaparinux |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An International, Randomized, Double-Blind Study Evaluating the Efficacy and Safety of Fondaparinux Versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-Segment Elevation MI Acute Coronary Syndromes |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Canadian Cardiovascular Collaboration, | Canadian Cardiovascular Collaboration, Population Health Research Institute |
Study ID Numbers: | EFC3197, SR90107 |
Study First Received: | August 29, 2005 |
Last Updated: | September 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00139815 |
Health Authority: | United States: Food and Drug Administration |
Heart Diseases Myocardial Ischemia Angina Pectoris Vascular Diseases Fondaparinux Pain Ischemia Org 31540 |
Enoxaparin Chest Pain Signs and Symptoms Necrosis Acute Coronary Syndrome Infarction Myocardial Infarction Angina, Unstable |
Fibrin Modulating Agents Anticoagulants Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |