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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00077818 |
Purpose
The purpose of this study is to determine the efficacy and safety of enoxaparin compared to unfractionated heparin (UFH) for patients diagnosed with Acute Coronary Syndrome (ACS) in the emergency department (ED). Efficacy is assessed by using a composite score consisting of 30-day all-cause mortality, non-fatal myocardial infarction (MI) and recurrent angina requiring revascularization.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome |
Drug: Enoxaparin sodium |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Prospective, Open-label, Randomized, Parallel-group Investigation to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in Subjects Who Present to the Emergency Department With Acute Coronary Syndrome |
| Study Start Date: | June 2002 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
EXCLUSION CRITERIA
Increased bleeding risk as defined by any of the following:
Impaired hemostasis including any one of the following:
Angina from a secondary cause such as:
Contacts and Locations
More Information
| Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
| Study ID Numbers: | XRP4563B_4001 |
| Study First Received: | February 12, 2004 |
| Last Updated: | October 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00077818 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Disease Attributes Disease Heart Diseases Anticoagulants Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Heparin, Low-Molecular-Weight Hematologic Agents Vascular Diseases Fibrinolytic Agents |
Cardiovascular Agents Pharmacologic Actions Enoxaparin Fibrin Modulating Agents Pathologic Processes Therapeutic Uses Syndrome Acute Coronary Syndrome Emergencies Cardiovascular Diseases |