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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00077844
First received: February 12, 2004
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Percutaneous Coronary Intervention
Drug: Enoxaparin sodium
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

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

Estimated Enrollment: 3532
Study Start Date: January 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (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

  • 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

EXCLUSION CRITERIA

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00077844

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Luc Sagnard Sanofi
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00077844     History of Changes
Other Study ID Numbers: XRP4563_4001, EudraCT #: 2004-003743-44
Study First Received: February 12, 2004
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heparin
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014