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Status:

COMPLETED

Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)

Lead Sponsor:

Sanofi

Conditions:

Myocardial Infarction

Acute ST-Segment Elevation

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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-infarctio...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2002

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2006

    Estimated Enrollment :

    20506 Patients enrolled

    Trial Details

    Trial ID

    NCT00077792

    Start Date

    October 1 2002

    End Date

    December 1 2006

    Last Update

    April 20 2009

    Active Locations (48)

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    Page 1 of 12 (48 locations)

    1

    Sanofi-Aventis Administrative Office

    Bridgewater, New Jersey, United States, 08807-0890

    2

    sanofi-aventis administrative Office

    Buenos Aires, Argentina

    3

    sanofi-aventis Australia & New Zealand administrative office

    Macquarie Park, Australia

    4

    Sanofi-Aventis Administrative Office

    Vienna, Austria