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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00077792
First Posted: February 16, 2004
Last Update Posted: April 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077792


  Show 48 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00077792     History of Changes
Other Study ID Numbers: EFC6147
XRP4563B/3001
First Submitted: February 12, 2004
First Posted: February 16, 2004
Last Update Posted: April 20, 2009
Last Verified: April 2009

Keywords provided by Sanofi:
Receiving fibrinolytic therapy

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases