Clinical Trials Directory

Trials / Completed

CompletedNCT00077844

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

Status
Completed
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
3,532 (estimated)
Sponsor
Sanofi · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGEnoxaparin sodium

Timeline

Start date
2004-01-01
Primary completion
2005-09-01
Completion
2005-09-01
First posted
2004-02-18
Last updated
2011-01-11

Source: ClinicalTrials.gov record NCT00077844. Inclusion in this directory is not an endorsement.