Status:
COMPLETED
Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI) Patients, an International Randomized Evaluation (STEEPLE)
Lead Sponsor:
Sanofi
Conditions:
Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 measu...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2005
Estimated Enrollment :
3532 Patients enrolled
Trial Details
Trial ID
NCT00077844
Start Date
January 1 2004
End Date
September 1 2005
Last Update
January 11 2011
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