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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00077792 |
The primary objective of the study is to determine whether enoxaparin compared to unfractionated heparin will reduce the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction within 30 days after randomization in patients with acute ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy
Condition | Intervention | Phase |
---|---|---|
Myocardial Infarction Acute ST-Segment Elevation |
Drug: Enoxaparin sodium (XRP4563) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Double-Dummy , Parallel Group, Multinational, Clinical Study to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in Patients With Acute ST-Segment Elevation Myocardial Infarction Receiving Fibrinolytic Therapy |
Enrollment: | 20506 |
Study Start Date: | October 2002 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Patients with ST-segment elevation acute myocardial infarction meeting all of the following criteria:
EXCLUSION CRITERIA:
Cardiovascular
Hemorrhagic Risk
Prior or Concomitant Pharmacologic Therapy
General
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC6147, XRP4563B/3001 |
Study First Received: | February 12, 2004 |
Last Updated: | April 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00077792 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Receiving fibrinolytic therapy |
Heart Diseases Anticoagulants Myocardial Ischemia Heparin, Low-Molecular-Weight Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Ischemia |
Calcium heparin Enoxaparin Fibrin Modulating Agents Necrosis Infarction Myocardial Infarction Heparin |
Heart Diseases Anticoagulants Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Hematologic Agents Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Ischemia |
Pharmacologic Actions Enoxaparin Fibrin Modulating Agents Necrosis Pathologic Processes Therapeutic Uses Cardiovascular Diseases Infarction Myocardial Infarction |