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

Study Overview
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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.

Official Title
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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

Conditions
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Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Enoxaparin sodium


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enoxaparin sodium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the composite of non-CABG major and minor bleeding |  | up to H48 after index PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of achieving ACT target range |  | at the beginning and end of procedure |