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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00077818 History of Changes |
| Other Study ID Numbers: | XRP4563B_4001 |
| Study First Received: | February 12, 2004 |
| Last Updated: | October 14, 2009 |
| Health Authority: | United States: Food and Drug Administration |
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Emergencies Acute Coronary Syndrome Disease Attributes Pathologic Processes Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain Pain Signs and Symptoms |
Calcium heparin Heparin Enoxaparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |