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

Phase 2

Completed

• Conditions: Percutaneous Coronary Intervention

• Registration Number: NCT00077844
• Lead Sponsor: Sanofi

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 measuring the incidence of non-coronary artery bypass graft (CABG) major and minor bleeding.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2004-02-12
• Study First Submitted QC: 2004-02-17
• Study First Posted: 2004-02-18
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-10
• Last Update Posted: 2011-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3532

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the composite of non-CABG major and minor bleeding	up to H48 after index PCI

Secondary Outcome Measures

Name	Time	Method
success rate of achieving ACT target range	at the beginning and end of procedure