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

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Descriptive Information Fields

Brief Title ^†

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

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

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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Percutaneous Coronary Intervention

Intervention ^†

Drug: Enoxaparin sodium

MEDLINE PMIDs

16957147, 18276619

Links

information on study results This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

3532

Start Date ^†

January 2004

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00077844

Organization ID

XRP4563/4001

Secondary IDs ^††

EudraCT #: 2004-003743-44

Study Sponsor ^†

Sanofi-Aventis

Collaborators ^††

Investigators ^†

Study Director:

Luc Sagnard

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

September 2008

First Received Date ^†

February 12, 2004

Last Updated Date

September 15, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.