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

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Enoxaparin; Enoxaparin sodium

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