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

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

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.

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