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Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI) Patients, an International Randomized Evaluation (STEEPLE)

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ClinicalTrials.gov Identifier: NCT00077844
Recruitment Status : Completed
First Posted : February 18, 2004
Last Update Posted : January 11, 2011
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of intravenous enoxaparin versus intravenous unfractionated heparin (UFH) in patients undergoing non-emergent PCI, as assessed by measuring the incidence of non-coronary artery bypass graft (CABG) major and minor bleeding.

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Drug: Enoxaparin sodium Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3532 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An International Phase 2-3, Stratified, Randomized, Open-label, Parallel-group Clinical Trial to Evaluate the Safety and Efficacy of a Single Intravenous Bolus of Enoxaparin Versus Intravenous Unfractionated Heparin in Patients Undergoing Non-emergent Percutaneous Coronary Intervention
Study Start Date : January 2004
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. the composite of non-CABG major and minor bleeding [ Time Frame: up to H48 after index PCI ]

Secondary Outcome Measures :
  1. success rate of achieving ACT target range [ Time Frame: at the beginning and end of procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Male or non-pregnant female greater than or equal to 18 years of age
  • Undergoing non-emergent single or multiple sites/vessels PCI during the same procedure
  • PCI to be performed with a femoral approach


  • Known or suspected pregnancy in women of childbearing potential
  • Thrombolytic therapy within the previous 24 hours
  • Undergoing primary PCI for ongoing ST-segment elevation myocardial infarction (STEMI)
  • Undergoing rescue PCI after failed thrombolysis
  • Any other elective PCI scheduled within the following 30 days after the index PCI
  • Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, intracranial tumor or aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery); active bleeding
  • Uncontrolled arterial hypertension
  • Recent (<48 hours) or planned spinal/epidural anesthesia or puncture
  • Impaired haemostasis: known International Normalized Ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL)
  • History of hypersensitivity or contraindication to heparin or LMWH
  • Treatment with oral anticoagulant therapy within 72 hours prior to inclusion or current need for vitamin-K antagonist therapy
  • Treatment with a direct thrombin inhibitor, low molecular weight heparin, or unfractionated heparin within the 24 hours preceding enrolment
  • Use of abciximab within the previous 7 days or, tirofiban, or eptifibatide within the past 12 hours of index PCI
  • Inability to give informed consent or high likelihood of being unavailable for follow-up
  • Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrollment in this trial

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): NCT00077844

Sponsors and Collaborators
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Study Director: Luc Sagnard Sanofi
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00077844    
Other Study ID Numbers: XRP4563_4001
EudraCT #: 2004-003743-44
First Posted: February 18, 2004    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Enoxaparin sodium
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action