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Safety and Efficacy of Enoxap...

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

Last Updated: 2011-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

3532 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Enoxaparin sodium

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers