|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00077792 |
Purpose
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) |
Eligibility| 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
Contacts and Locations
Show 48 Study Locations| Study Director: | ICD CSD | Sanofi-Aventis |
More Information
| 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 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 |