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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
Sponsored by: 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

MedlinePlus related topics: Blood Thinners Heart Attack
Drug Information available for: Enoxaparin Sodium
U.S. FDA Resources
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

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

  Show 48 Study Locations
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

Study placed in the following topic categories:
Heart Diseases
Anticoagulants
Myocardial Ischemia
Heparin, Low-Molecular-Weight
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Ischemia
Calcium heparin
Enoxaparin
Fibrin Modulating Agents
Necrosis
Infarction
Myocardial Infarction
Heparin

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 May 07, 2009