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| 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
Hide Study Locations| United States, New Jersey | |
| Sanofi-aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807-0890 | |
| Argentina | |
| sanofi-aventis administrative Office | |
| Buenos Aires, Argentina | |
| Australia | |
| sanofi-aventis Australia & New Zealand administrative office | |
| Macquarie Park, Australia | |
| Austria | |
| Sanofi-aventis Administrative Office | |
| Vienna, Austria | |
| Belarus | |
| Sanofi-aventis Administrative Office | |
| Minsk, Belarus | |
| Belgium | |
| Sanofi-aventis Administrative Office | |
| Diegem, Belgium | |
| Brazil | |
| Sanofi-aventis Administrative Office | |
| Sao Paulo, Brazil | |
| Bulgaria | |
| Sanofi-aventis Administrative Office | |
| Sofia, Bulgaria | |
| Canada | |
| Sanofi-aventis Administrative Office | |
| Laval, Canada | |
| Chile | |
| Sanofi-aventis Administrative Office | |
| Santiago, Chile | |
| China | |
| Sanofi-aventis Administrative Office | |
| Shangaï, China | |
| Croatia | |
| Sanofi-aventis Administrative Office | |
| Zagreb, Croatia | |
| Denmark | |
| Sanofi-aventis Administrative Office | |
| Horsholm, Denmark | |
| Estonia | |
| Sanofi-aventis Administrative Office | |
| Tallinn, Estonia | |
| Finland | |
| Sanofi-aventis Administrative Office | |
| Helsinki, Finland | |
| France | |
| Sanofi- Aventis Administrative Office | |
| Paris, France | |
| Germany | |
| Sanofi-aventis Administrative Office | |
| Berlin, Germany | |
| Greece | |
| Sanofi-aventis Administrative Office | |
| Athens, Greece | |
| Hong Kong | |
| Sanofi-aventis Administrative Office | |
| Causeway Bay, Hong Kong | |
| Hungary | |
| Sanofi-aventis Administrative Office | |
| Budapest, Hungary | |
| India | |
| Sanofi-aventis Administrative Office | |
| Mumbai, India | |
| Ireland | |
| Sanofi-aventis Administrative Office | |
| Dublin, Ireland | |
| Israel | |
| Sanofi-aventis Administrative Office | |
| Natanya, Israel | |
| Italy | |
| Sanofi-aventis Administrative Office | |
| Milano, Italy | |
| Jordan | |
| Sanofi-aventis Administrative Office | |
| Amman, Jordan | |
| Korea, Republic of | |
| Sanofi-aventis Administrative Office | |
| Seoul, Korea, Republic of | |
| Latvia | |
| Sanofi-aventis Administrative Office | |
| Riga, Latvia | |
| Lebanon | |
| Sanofi-aventis Administrative Office | |
| Beirut, Lebanon | |
| Lithuania | |
| Sanofi-aventis Administrative Office | |
| Vilnius, Lithuania | |
| Malaysia | |
| Sanofi-aventis Administrative Office | |
| Kuala Lumpur, Malaysia | |
| Mexico | |
| Sanofi-aventis Administrative Office | |
| Mexico, Mexico | |
| Netherlands | |
| Sanofi-aventis Administrative Office | |
| Gouda, Netherlands | |
| Norway | |
| Sanofi-aventis Administrative Office | |
| Lysaker, Norway | |
| Poland | |
| Sanofi-aventis Administrative Office | |
| Warszawa, Poland | |
| Portugal | |
| Sanofi-aventis Administrative Office | |
| Porto Salvo, Portugal | |
| Romania | |
| Sanofi-aventis Administrative Office | |
| Bucuresti, Romania | |
| Russian Federation | |
| Sanofi-aventis Administrative Office | |
| Moscow, Russian Federation | |
| Singapore | |
| Sanofi-aventis Administrative Office | |
| Singapore, Singapore | |
| Slovakia | |
| Sanofi-aventis Administrative Office | |
| Bratislava, Slovakia | |
| South Africa | |
| Sanofi-aventis Administrative Office | |
| Midrand, South Africa | |
| Spain | |
| Sanofi-aventis Administrative Office | |
| Barcelona, Spain | |
| Sweden | |
| Sanofi-aventis Administrative Office | |
| Bromma, Sweden | |
| Switzerland | |
| Sanofi-aventis Administrative Office | |
| Geneva, Switzerland | |
| Thailand | |
| Sanofi-aventis Administrative Office | |
| Bangkok, Thailand | |
| Turkey | |
| Sanofi-aventis Administrative Office | |
| Istanbul, Turkey | |
| Ukraine | |
| Sanofi-aventis Administrative Office | |
| Kiev, Ukraine | |
| United Kingdom | |
| Sanofi-aventis adminsitrative office | |
| Guildford Surrey, United Kingdom | |
| Uruguay | |
| Sanofi-aventis Administrative Office | |
| Montevideo, Uruguay | |
| 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 |