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Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)
This study has been completed.
First Received: February 12, 2004   Last Updated: April 17, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Composite of all-cause mortality and non-fatal myocardial re-infarction

Secondary Outcome Measures:
  • Composite of all-cause mortality, non-fatal myocardial re-infarction, and myocardial ischemia leading to urgent revascularization and non-fatal disabling stroke

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
Criteria

INCLUSION CRITERIA:

Patients with ST-segment elevation acute myocardial infarction meeting all of the following criteria:

  • Male or non-pregnant female greater than or equal to 18 years of age (depending on local regulations, minimal age can vary between 18 and 21 years)
  • Onset of prolonged (greater than or equal to 20 min) ischemic symptoms at rest less than or equal to 6 hours prior to randomization
  • ST-segment elevation of 0.1 mV in 2 or more limb leads, or 0.2 mV in two (2) or more contiguous precordial leads, or left bundle-branch block
  • Planned reperfusion therapy with streptokinase, tenecteplase, alteplase or reteplase
  • Written informed consent will be obtained

EXCLUSION CRITERIA:

Cardiovascular

  • Evidence of cardiogenic shock at randomization
  • Acute pericarditis
  • History or symptoms suggestive of aortic dissection
  • MI precipitated by obvious provoking factors such as arrhythmia, infection, severe anemia, hyperthyroidism, cocaine, or amphetamine

Hemorrhagic Risk

  • Any minor head trauma or any other trauma occurring after the index acute myocardial infarction
  • Active or recent (< 3 months) bleeding including gastrointestinal bleeding, known presence of occult blood in the stool, or gross hematuria.
  • Any history of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia
  • Any single reliable recording of systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg prior to randomization
  • Any history of stroke or transient ischemic attack; any history of hemorrhagic cerebrovascular disease
  • Any known structural damage or other pathologic process involving the central nervous system
  • Any head trauma within 6 months prior to randomization
  • Major surgery (including CABG), any ophthalmologic surgery, or non-cutaneous biopsy, or substantial trauma within 3 months prior to randomization
  • Traumatic or prolonged cardiopulmonary resuscitation (> 2 minutes) within 2 weeks prior to randomization
  • Puncture of a non-compressible vessel (artery or vein) within the 24 hours prior to randomization
  • Acute peptic ulcer disease within 3 months prior to randomization

Prior or Concomitant Pharmacologic Therapy

  • Administration of abciximab (ReoPro), within the previous 7 days or eptifibatide (Integrilin), or tirofiban (Aggrastat) within the previous 24 hours prior to randomization
  • Current therapy with oral anticoagulants, or an International Normalized Ratio of >1.5
  • Administration of a low molecular weight heparin within 8 hours prior to randomization.
  • Known hypersensitivity to low molecular weight heparins, unfractionated heparin or heparin-like products; allergy to pork or pork products
  • Known hypersensitivity and/or contra-indication(s) to fibrinolytic drugs (streptokinase, tenecteplase, alteplase and reteplase)

General

  • Known platelet count <100,000 cells/microL or history of heparin-induced thrombocytopenia
  • Known clinically significant anemia (Hemoglobin <10 g/dL which is < 6.2 mmol/L)
  • Known renal insufficiency with serum creatinine >220 mmol/L (2.5 mg/dL) for men and >175 mmol/L (2.0 mg/dL) for women when assessed prior to baseline examination.
  • Advanced neoplastic or other life-threatening disease with a life expectancy of <12 months
  • Pregnancy or parturition within the last 90 days or currently breast feeding
  • Women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having a negative pregnancy test.
  • Treatment with other investigational agents in the last 30 days before study entry or previous enrollment in ExTRACT-TIMI 25
  • History of drug or alcohol abuse
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study
  • Any patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and who are unlikely to complete the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077792

  Hide Study Locations
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
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: ICD CSD Sanofi-Aventis
  More Information

Additional Information:
Publications:
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

Keywords provided by Sanofi-Aventis:
Receiving fibrinolytic therapy

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 22, 2009